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ICU Medical jobs in San Clemente, CA

- 219 jobs
  • Associate Hospital Sales Representative - DSS West

    ICU Medical 4.8company rating

    ICU Medical job in San Clemente, CA

    The Associate Hospital Sales Representative is responsible for building and maintaining relationships with internal and external stakeholders and key decision makers that lead to future business opportunities. The position increases profitability and expands existing accounts by selling ICU Medical products and extending relationships into new areas with new accounts. This is an entry-level role designed to provide new representatives with comprehensive training, hands-on experience, and a well-rounded understanding of ICU Medical's business operations, products, and sales strategy. The position serves as a foundational stepping stone for high-potential individuals seeking to build a long-term career in medical sales. Successful candidates will be considered for promotion to a field-based Sales Representative role within 12-18 months, contingent on performance, business needs, and the availability of open territories. Candidates must be willing and prepared to relocate for promotion opportunities as they arise. Essential Duties & Responsibilities Meet territory sales quota and effectively manage CRM pipeline for ICU Medical Infusion Therapy, Devices, Oncology, Specialty products, and Services Master presentation skills and share technical knowledge of the ICU family of products and how they relate to guidelines FDA, CDC, SHEA, INS, ONS, ASHP, etc. in order to communicate professionally with Hospital Clinicians Know the strengths and weaknesses of competing products in the market and how to position ICU Medical's offerings against them clinically. Be the clinical expert / consultative problem solver at the field level for clinical and supply chain contacts. Know the assigned territory and customer base, contracts, pumps, solutions, distribution models, etc. Be able to conduct product demos of all ICU products and conduct customer meetings Communicate with sales teams and managers to align sales efforts with Company and regional targets Support field sales in managing customer communications related to backorders, allocations, pricing, contracts, etc. Work on special projects as assigned and attend all team, regional, and office hours calls Travel outside of territory monthly to assist with educations, go-lives, implementations, assessments, etc. Knowledge & Skills Self-motivated, energetic, professional, and able to perform job duties with minimal supervision Excellent verbal and written communication skills Strong presentation skills Strong organization skills and able to multitask Computer literate and proficient in Excel, Word, and Outlook Minimum Qualifications, Education & Experience Must be at least 18 years of age Bachelor's degree from an accredited college or university is required Position requires active and current compliance with all credentialing requirements, including COVID-19 vaccination, to perform the essential function of your role at customer locations. Work Environment This job is a field-based role. Work may be performed in a home office using standard office equipment, as well as on-site at customer locations. While performing the duties of this job, the employee may be required to sit, stand and walk for long periods of time; depending on the needs of a customer As part of the scope of employment, the employee must hold a valid driver's license as well as comply and meet the requirements set forth in the Authorized Driver Policy to drive on behalf of the company. Typically requires travel more than 50% of the time
    $103k-131k yearly est. Auto-Apply 53d ago
  • Respiratory Care Sales Specialist - Northern California/Northern Nevada

    ICU Medical 4.8company rating

    ICU Medical job in San Clemente, CA

    The Respiratory Sales Specialist is responsible for building and maintaining ICU Medical's Respiratory Care business in a given territory. The Respiratory Sales Specialist is responsible for building and maintaining relationships with key decision makers that lead to the stabilization of current business and development of future business opportunities. The position increases profitability and expands existing accounts by selling ICU Medical products and extending relationships into new areas with new accounts in both the acute and non-acute customer segments. The Respiratory Sales specialist is also responsible for providing post sales implementation support on an ongoing basis to ensure ICU Medical customers are maintaining an overall positive experience. Essential Duties & Responsibilities Meet territory sales revenue objectives for ICU Medical, Inc. Respiratory Care product line, including Tracheostomy Products (Bivona, Portex Anesthesia Airway, BLUselect Trach Tubes, BLUperc Percutaneous, Kits/Trays, Custom Tracheostomy); Bronchial Hygiene Products (Acapella, TheraPEP, EZPAP, Coach 2); Respiratory Products (Resuscitation, Closed Suction, Pressure Easy Cuff, Secure Easy); Pneupac Ventilation (para PAC Plus, baby PAC); and BCI Patient Monitoring (Pulse Oximeters, Handheld Capnography). Master presentation skills and command technical knowledge of the ICU family of products to be able to clearly and professionally communicate the clinical benefits to Hospital and Non-Acute Care Setting Clinicians. Master presentation skills and command technical knowledge of the ICU family of products and how they relate to industry guidelines. Know the strengths and weaknesses of competing products in the market and how to position ICU Medical's offerings against them clinically. Be the clinical expert/consultative problem solver at the field level for clinical and supply chain contacts. Know the assigned territory and customer base, contracts, competitive product, distribution models, etc. Be able to conduct product trials and implementation of all ICU products in the Respiratory Care product portfolio. Know your market and the clinicians in the market through local SCCM, AARC, and ATS. Communicate with managers and align sales efforts with company and regional targets. Work on special projects as they arise and are assigned. Work occasionally during weekends/nights, when necessary Knowledge & Skills Prior Respiratory and/or medical device sales experience is a requirement. Strategic mindset with the ability to develop and execute a business plan to increase market share at strategic accounts that have substantial influence on specification decisions within the clinical community. Proven ability to drive sales growth and deliver results through process-oriented data-driven continuous improvement tools and methods (sales funnel process, gap analysis, value selling, etc.) Self-motivated, energetic, professional, and able to perform job duties with minimal supervision. Excellent verbal and written communication skills, and strong presentation skills with the ability to adapt and articulate ICU Medical Respiratory Care value proposition to a wide variety of decision makers. Strong organizational skills and able to multitask. Computer literate and proficient in Excel, Word, and Outlook Minimum Qualifications, Education & Experience Must be at least 21 years of age. Bachelor's degree from an accredited college or university is required. Minimum 3 years of sales experience with a proven track record of success. Preferably in medical device sales with relationships in key regional health systems, as well as experience in Respiratory therapy products and services. Tracheostomy or Respiratory therapy products are preferred background. Proven track record of making quota/growth in territory, development of existing customer relationships with Supply Chain. Position requires active and current compliance with all credentialing requirements, including COVID-19 vaccination, to perform the essential function of your role at customer locations. Work Environment This job is a field-based role. Work may be performed in a home office using standard office equipment, as well as on-site at customer locations. While performing the duties of this job, the employee may be required to sit, stand, and walk for long periods of time, depending on the needs of a customer. As part of the scope of employment, the employee must hold a valid driver's license as well as comply and meet the requirements set forth in the Authorized Driver Policy to drive on behalf of the company. Typically requires travel more than 50% of the time.
    $87k-127k yearly est. Auto-Apply 55d ago
  • Manufacturing Specialist

    Gilead Sciences 4.5company rating

    La Verne, CA job

    At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. As a (Manufacturing Specialist), you are responsible for: Key Responsibilities: Demonstrates hands-on technical leadership of process development, technology transfer, and process operations within a phase appropriate cGMP environment. Responsible for executing technology/process transfer from Lab to manufacturing production floor and provide technical input and support during manufacturing of drug products. Lead the design and development of downstream processes, including design of experiments, process optimization, data interpretation and analysis. Author or review technical documentation (development reports, process description, process flow protocols, batch records, etc) Mentor junior team members on process operations and development strategies, experimental design and execution as well as process transfer. Participate in cross functional initiatives, Adhere to department budget and all training, compliance, and safety requirements. Basic Qualifications: M.S. with 2+ years or BS with 4+ years' experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering). Preferred Qualifications: Strong understanding of biologics/sterile injectable product manufacturing processes e.g., bulk freeze/thaw, mixing/pooling, filtration, filling and/or lyophilization Experience supporting drug product manufacturing operations, technology transfer, and/or development. Prior experience with commercial manufacturing and/or process validation is highly desirable. Hands-on experience with process operations including centrifugation, normal flow filtration, high throughput purification screening and development, chromatography operations, tangential flow filtration, formulation development and technical transfer. Broad understanding of downstream development and scale up including process transfers for new product introduction into the production lines. Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities. Working knowledge of cGMPs and regulatory requirements of biopharmaceutical manufacturing Experience in cleaning process design, verification, and cross contamination strategies. Motivated self-starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation, and scientific writing skills The salary range for this position is: $107,185.00 - $138,710.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
    $107.2k-138.7k yearly Auto-Apply 60d+ ago
  • Director, Global Environmental, Product Stewardship, and Supply Chain Counsel

    Edwards Lifesciences 4.6company rating

    Irvine, CA job

    Make a meaningful difference to patients around the world. Our Legal team works to protect our patients, team members, and innovations with the utmost diligence and care. You'll have the opportunity to work with a dedicated team and build lasting partnerships with stakeholders across our global organization. Your legal knowledge and contributions will help us ensure that we are supporting the needs and interests of the patients we serve. This is an on-site position (on-site minimally 4 days per week). How you'll make an impact: This Director, Global Environmental, Product Stewardship, and Supply Chain Counsel (Edwards title is Director, Corporate Counsel) will play a crucial role in supporting our environmental policies and ensuring compliance with relevant laws and regulations. You will also be responsible for advising on product stewardship initiatives, and overseeing supply chain legal matters. Provide legal guidance on global environmental regulations and compliance to ensure the company's operations adhere to local, national, and international standards. Advise on global product stewardship issues, including safe and sustainable product design, lifecycle management, and responsible disposal. Oversee legal aspects of supply chain management, including trade compliance and risk assessments. Collaborate with cross-functional teams to develop and implement applicable policies. Stay informed on current and emerging laws and trends and proactively address potential legal challenges. Support the company in negotiations, regulatory discussions, and compliance audits. Draft, review, and revise legal documents related to environmental, product stewardship, and supply chain matters What you'll need (required): Juris Doctor or equivalent from an ABA-accredited law school with 8 years experience in environmental regulations, product stewardship, or related field Relevant industry experience (e.g., medical device, pharmaceuticals, etc.) or in highly regulated environments What else we look for (preferred): Experience with materials compliance highly preferred Expertise in international environmental product directives and guidance (REACH, RoHS, EU Battery Regulation, POPs, SCIP) Experience supporting a Global Supply Chain organization Experience with trade compliance Excellent analytical, detail-oriented and information seeking skills Excellent organization and time management skills Excellent written and verbal communication skills and interpersonal relationship skills with ability to drive achievement of objective Strict attention to detail Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization Ability to manage competing priorities in a fast-paced environment Represent leadership on projects within multiple areas, interfacing with project managers, legal team and middle management Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $170,000 to $241,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
    $170k-241k yearly Auto-Apply 49d ago
  • Senior Scientist in Biologics Analytical Development (Pivotal and Commercial)

    Gilead Sciences 4.5company rating

    Oceanside, CA job

    At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description The Analytical Operations department is seeking a highly motivated Senior Scientist to lead our impurities development team. The ideal candidate must possess strong leadership skills to drive the development and testing of ELISA (host cell protein, protein A), DNA, and other kinetic or end-point plate-based assays. A strong understanding of regulatory expectations, risk assessment, and impurity profiling in biopharmaceutical development is essential. The candidate should be adept at troubleshooting complex assays, interpreting data, and driving innovation in HCP monitoring to support process development and product characterization. Additionally, the ideal candidate should have experience working with pharmacopeial standards (e.g., USP, EP, JP), and have familiarity with regulatory expectations and quality control environments. The candidate should be capable of interpreting compendial updates, ensuring compliance, and supporting cross-functional teams in method lifecycle management and troubleshooting. At a future date, this position will relocate from Oceanside CA to the Gilead corporate HQ in Foster City CA or will be hired directly to Foster City CA. Responsibilities: Provide leadership to a group of scientists focused on impurities and compendial method development and testing and product understanding, including: Mentor and guide scientists in their roles. Set clear expectations and prioritize work packages. Recruit and hire new talent. Accountable for: Defining process impurity and compendial testing and control strategy across the late-phase biologics portfolio. Driving continuous improvement of process impurity strategies. Support the design/justification/execution of end-to-end control strategy development through a proactive definition of the product quality targets. Delivering high quality work packages for supporting Pivotal INDa and marketing applications. Serve as an analytical development (AD) lead or analytical project lead (ASTL) for late-phase program. Serve as an author and reviewer of CMC sections in regulatory filings, and support interactions with health agencies. Collaborate across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ensure timely delivery and successful commercialization of the late-stage Biologics portfolio. Act as a key member of the extended Analytical Development leadership team to shape late-stage development strategies. Recruit, hire, and mentor talent to help cultivate a world class Biologics AD organization. Basic Qualifications: 8+ Years with BS OR 6+ Years with MS OR 2+ Years with PhD/PharmD OR 0+Years with MD Preferred Qualifications: PhD in Chemistry or a related discipline with at least 3 years industry experience, or BS or MS degree with extensive industry experience. Significant expertise in HCP, host cell DNA, and other process related impurity method development and techniques commonly used for drug substance release testing and process characterization (e.g. ELISA). Subject matter expert in establishing comprehensive control strategies for biologics products. Well versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product. Proven track record in drafting regulatory documentation at all stages, including IND, BLA, and PAS filings. Demonstrated ability of building strong collaborations with other CMC functions. Strong business acumen, with ability to balance resource, budget, and program milestones. Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, strategic vision, executive presence. Ability to build high performing teams and to set clear and measurable goals for staff and prioritize projects and resources. People leader accountabilities •Create inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. •Develop talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. •Empower teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. The salary range for this position is: Other US Locations: $153,935.00 - $199,210.00. Bay Area: $169,320.00 - $219,120.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
    $169.3k-219.1k yearly Auto-Apply 60d+ ago
  • Specialist, Regulatory Affairs THV

    Edwards Lifesciences 4.6company rating

    Irvine, CA job

    Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients' lives. Aortic stenosis & aortic regurgitation impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management Prepare and oversee documentation packages for submission to global regulatory agencies. Track timelines and documents milestone achievements for inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review and on-site audit support (e.g., IDE's, PMA's, annual reports, 510(k)'s, STED's and CE marking design dossiers and technical files) Provide guidance on regulatory requirements necessary for contingency planning Monitor proposed and current global regulations and guidance; assesses impact of such regulations and guidance on assigned project(s); proposes suggestions on utilizing regulatory updates to expedite approval process Review labeling content, product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy Prepare documents for submissions, including assuring the appropriate forms for all of the global regulatory bodies; assist with GUDID submissions What you will need (Required): Bachelor's Degree & a minimum of 3 years related experience or equivalent experience based on Edwards criteria Coursework, seminars, and/or other formal government and/or trade association training What else we look for (Preferred): Bachelor's Degree in scientific discipline (e.g., Biology, Microbiology, Chemistry, Bioengineering) Experience in preparing domestic and international product submissions Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices Solid knowledge and understanding of global regulatory requirements for new products or product changes Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $72,000 to $102,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. #LI-Onsite Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
    $72k-102k yearly Auto-Apply 5d ago
  • Analyst, Clinical Contracts

    Edwards Lifesciences Corp 4.6company rating

    Irvine, CA job

    Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. As the Clinical Contracts Analyst, you will negotiate and develop contracts associated with clinical trials, ensure contracts comply with regulations and manage the lifecycle of contracts. This is a hybrid role (office and remote blend). Selected candidate must reside within a reasonable distance from the Irvine Corporate location and have ability to commute on required onsite days. . How you'll make an impact: * Initiate, draft, redline, and negotiate 3rd party moderately complex clinical related contracts (e.g. legal contract language and budgets) based on substantial knowledge of financial/fair market value, regulatory and clinical requirements while demonstrating clinical knowledge. Recommend new/or revised language for contract templates. * Identify risks (e.g. site incentives, legal issues, conflict of interest) and actively engage with management to provide recommendations for mitigation. Provide clinical input on functional contract terms, budgets, and scope of services to secure appropriate approvals in collaboration with key stakeholders (e.g. Clinical Affairs, Legal Compliance, Finance) * Analyze need for contract amendments or renewals and make recommendations, and/or negotiate changes, to terms and conditions * Identify risk associated with project timelines set by project teams, impacting team's deliverables and timelines, and key stakeholders' workload (e.g., Legal Compliance, legal contracts, legal privacy, and risk management) based on revised timelines. * Submit proposed final draft and supporting documentation through Legal Department's RFA system for contract approval and secure appropriate signatures within specified signing authority * Identify opportunities for process improvement in collaboration with cross-functional teams; present and implement process improvement plans to management and/or key stakeholders. * Other duties as apply What you'll need (Required): * Bachelors Degree in related field with 3 years experience of previous related work experience in contract negotiation/ administration and financial tracking/analysis against contracts required, or equivalent work experience based on Edwards criteria * Experience in healthcare related clinical contracts What else we look for (preferred): * Strong experience drafting, reviewing, and negotiating clinical study contracts, including familiarity with terms and conditions, regulatory compliance, and stakeholder collaboration * Previous clinical research/clinical trial experience * Contract/paralegal certification * Proven expertise in Microsoft Office Suite including Word, PowerPoint, Excel, and SharePoint * Moderate knowledge of medical terminology and healthcare compliance and privacy regulations (e.g. HIPAA and Sunshine Act) * Understanding of regulatory requirements (e.g., CFR, GCP) and documents * Ability to work in a team environment, including inter-departmental teams and representing the organization on specific projects * Ability to build stable internal/external working relationships * Ability to interact professionally with all organizational levels * Strict attention to detail For California, the base pay range for this position is $66,000 to $90,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
    $66k-90k yearly Auto-Apply 26d ago
  • Warehouse Associate, 2pm shift

    Owens & Minor 4.6company rating

    Ontario, CA job

    At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 350+ facilities across the US and 22,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care. Customers-and their patients-are at the heart of what we do. Our mission is to empower our customers to advance healthcare, and our success starts with our teammates. Owens & Minor teammate benefits include: Medical, dental, and vision insurance, available on first working day 401(k), eligibility after one year of service Employee stock purchase plan Tuition reimbursement The anticipated pay range for this role is as follows:$21.00 HourlyJob DescriptionPAY: $21/HR + 8% Shift Differential (~22.68) SHIFT 2PM - 10:30PM + Some OT; Split days off - (Saturday's off) RESPONSIBILITIES Overview: Pick products utilizing Voice / Vision Pick Technology and RF scanner then placing items into totes as directed by the voice/ vision picking system, and then move totes to an infeed, moving conveyor. Pick product in multiple units of measure (UOMs) - Case, Box, Ea., etc. Use a voice-activated handset to pick products. Use hand-held RF devices as needed to pick the products. Maintain established quality standards. Maintain established productivity standards. Perform basic math calculations. Maintains a clean and safe work environment. Occasionally lifting products up to 50 pounds. This job comprises tasks that are generally routine and repeated during the shift. Standing for long periods of time and some lifting is required. This list is not all inclusive to all the daily tasks and additional duties that can be assigned as directed. If you feel this opportunity could be the next step in your career, we encourage you to apply. Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.
    $21 hourly Auto-Apply 35d ago
  • Distribution Teammate - Equipment Operator

    Owens & Minor, Inc. 4.6company rating

    Ontario, CA job

    At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 350+ facilities across the US and 22,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care. Customers-and their patients-are at the heart of what we do. Our mission is to empower our customers to advance healthcare, and our success starts with our teammates. Owens & Minor teammate benefits include: * Medical, dental, and vision insurance, available on first working day * 401(k), eligibility after one year of service * Employee stock purchase plan * Tuition reimbursement The anticipated pay range for this role is as follows:$22.00 Hourly * SHIFT: Monday - Friday 8AM Start The Anticipated pay rate for this position is as follows: $22/hour POSITION SUMMARY Performs warehouse tasks within the Owens & Minor Distribution Center, primarily utilizing Material Handling Equipment (cherry picker, reach truck, double reach, sit down forklift, motorized pallet jack, etc.). Unloads, receives, and processes inbound shipments. Performs bin replenishment, moves product around the distribution center to ensure efficient processing, and prepares pick locations. Accurately picks, packs, sorts and loads outbound products in accordance with customer specifications. Ensures warehouse functions are completed safely, accurately, and on-time within company standards. RESPONSIBILITIES Bulk / Parcel Picking * Selects bulk items from warehouse racking using a stock picker and Voice Pick Technology and/or RF scanner. * Operates a forklift and picks items as high as 35 feet in the air. * Builds pallets and delivers them to designated area for shipping. * Sortation * Prepares sortation area by setting up pallets and carts for product. * Moves cartons and totes from conveyor belts and/or rollers and places on pallets and/or carts according to assigned batch. * Responsible for daily picking of Sm. Parcel, LTL, and TL orders. * Processing at workstation picked orders. * Picking & processing sample orders Loading/ Unloading * Moves pallets and/or cases from reserve location to pick location using a standing reach truck, stock picker, or sit-down forklift. * Uses RF scanner to ensure that totes, pallets, and carts are loaded correctly onto trucks for customer delivery. * Uses sit down forklift, electric or manual pallet jack to load pallets. * Unloads pallets and cases from inbound trailers and/or containers manually and/or using MHE to include manual pallet jack, motorized pallet jack, sit down or standup forklift, and standing reach truck. * Accurately counts, verifies, and receives product using radio frequency (RF) equipment and/or Voice Pick Technology, documents variances. * Uses RF scanner to ensure that totes, pallets, and carts are loaded correctly onto trucks for customer delivery. * Uses sit down forklift, electric or manual pallet jack to load pallets General requirements for all functions: * Operates various MHE and follows general sequencing and process procedures. * Maintains a safe and clean work environment. * Follows safety policies and procedures and corrects or communicates hazards to management. * Places incoming merchandise into inventory. * Conducts physical inventories as required. * Counts and performs basic math calculations. * Maintains productivity and quality standards. * Performs additional duties as directed. EDUCATION & EXPERIENCE * General knowledge of a variety of basic topics (math, reading, basic accounting, typing, etc.) * Prior experience working in a warehouse/distribution center a plus. * Warehouse/Operations certification a plus KNOWLEDGE, SKILLS, & ABILITIES * Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagrammatic form * Ability to work in a fast-paced, team environment and meet performance standards/individual performance goals * Good attention to detail * Dependable and able to report to work as scheduled/have regular punctual attendance * Willingness to learn how to use new material handling equipment * Willingness to learn WMS Technology * Ability to adhere to all Standard Operating Procedures for safety rules and requirements received in training ADDITIONAL REQUIREMENTS * Must successfully pass pre-employment drug screen and background check * Ability to frequently work unscheduled overtime hours with minimal notice * Ability to work nights, weekends, and holidays as needed * For some functions, must be able to operate forklift and pick items as high as 35 feet in the air * Must be able to stand and walk on concrete warehouse floors for long periods of time * Must be able to squat and kneel often, and lift up to 50 lbs. individually or greater than 50 lbs. in a team lift * Must be able to safely use a step ladder or stool to reach area shelves * Must be able to safely wear steel-toed protective footwear in accordance with the OSHA General Industry standard * Must be able to safely use a provided box cutter * Must be able to move up and down multi-level stairways safely * Must be able to clearly communicate (speak and understand) in English in order to operate voice-pick technology If you feel this opportunity could be the next step in your career, we encourage you to apply. Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.
    $22 hourly Auto-Apply 11d ago
  • Manager, Provider Education and Engagement Programs

    Edwards Lifesciences 4.6company rating

    Irvine, CA job

    Make a meaningful difference to patients around the world. Driven by a passion to help patients live healthier and more productive lives, our Sales teams embrace Edwards Lifesciences' values to build trusting, lasting relationships with medical professionals and industry partners. Your insight and dedication will help deepen and broaden clinical knowledge of our company's innovative technologies, while creating connections between providers and teams across our businesses to ensure patients receive the highest quality of care. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The primary objective of the Manager, Provider Education and Engagement Programs - THV is to execute Transcatheter Heart Valve's (THV's) vision to ensure the availability of TAVR to all patients that are in need and meet the requirements for treatment through healthcare provider education and engagement. The Manager, Provider Education and Engagement Programs - THV will support the Provider Engagement and Strategic Sales Programs Team, with an emphasis on healthcare provider educational courses, resources, tools and engagement platforms. This role will provide expertise in execution of programs to drive adoption of TAVR and the betterment of patient care. How you'll make an impact: Executing educational offerings in collaboration with the team to meet the evolving landscape of structural heart care. Engaging with Key Opinion Leaders and leadership to discuss market opportunities. Develop and update educational content based on clinical evidence, FDA approvals, and market trends. Create training materials tailored to specific audiences, ensuring alignment with clinical data, industry trends, and regulatory requirements. Design and update training presentations and documents through Power Point and other platforms. Partner with internal teams (marketing, brand, communications, training, medical affairs, IT) and external advisors to align messaging and strategy. Engage SMEs to drive strategic collaboration and communication nationwide. Engage with field teams and leadership to educate on existing programs Collaborate across functions to support a wide variety of digital and live programs across the United States field team. Able to share key responsibilities and collaborate with team members Ability to drive the successful execution of a broader provider engagement strategy within a highly functional team environment Demonstrates commitment to shared responsibility and collective accountability within the team Execute and assist in managing Provider Engagement Training Programs Expertise and high utilization of Cvent, Salesforce, Excel, polling platforms, and Microsoft Office Ensure accurate documentation and enforce Edwards compliance standards Drive content through legal and regulatory approval processes. Lead corporate initiatives and process improvements that deliver organizational value. Investigate and implement automation tools to streamline program execution. Analyze program performance and market trends to inform strategy and program design. Maintain current knowledge of severe aortic stenosis, transcatheter aortic valve replacement, and relevant clinical data. Manage program-related budgets and payments. Communicate complex information with clarity and diplomacy across internal and external stakeholders. Execute and assist in managing Provider Engagement Training Programs. Ensure accurate documentation and enforce Edwards compliance standards. Drive content through legal and regulatory approval processes. Lead corporate initiatives and process improvements that deliver organizational value. What you'll need (Required): Bachelor's degree in related field with 8 years of previous experience required or equivalent work experience based on Edwards criteria. A willingness to travel up to 60% (includes car, air, overnight). What else we look for (Preferred): Expertise and high utilization of Cvent, Salesforce, Excel, polling platforms, and Microsoft Office. Investigate and implement automation tools to streamline program execution. Analyze program performance and market trends to inform strategy and program design. Maintain current knowledge of severe aortic stenosis, transcatheter aortic valve replacement, and relevant clinical data. Manage program-related budgets and payments. Communicate complex information with clarity and diplomacy across internal and external stakeholders. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $102,000 to $145,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
    $102k-145k yearly Auto-Apply 25d ago
  • Operations Supervisor - Repair

    Owens & Minor 4.6company rating

    Riverside, CA job

    At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 350+ facilities across the US and 22,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care. Customers-and their patients-are at the heart of what we do. Our mission is to empower our customers to advance healthcare, and our success starts with our teammates. Owens & Minor teammate benefits include: Medical, dental, and vision insurance, available on first working day 401(k), eligibility after one year of service Employee stock purchase plan Tuition reimbursement ABOUT THE COMPANY Apria Healthcare's mission is to improve the quality of life for our patients at home. We are looking for empathetic, thoughtful and compassionate people, to meet the needs of our patients. Already an industry leader in healthcare services, we provide home respiratory services and select medical equipment to help our patients sleep better, breathe better, heal faster, and thrive longer. JOB SUMMARY The Operation Supervisor Repair is responsible for the output of his/her Repair operation, including productivity of Repair Technicians, and departmental budget, costs and quality management. This role involves managing a team of technicians, coordinating the repair and refurbishment of equipment, and ensuring the timely delivery of repaired products to customers. The key responsibilities ensure a safe, healthy, and productive workplace for the continuous flow of clean, quality rental equipment to meet the needs of the branches/customers and support their growth. The anticipated salary range for this position is $65,000 - $70,000.(Annual) The actual compensation offered may vary based on job related factors such as experience, skills, education and location. Shift: M-F 6am-2:30pm ESSENTIAL DUTIES AND RESPONSIBILITIES Repair Operations & Workflow Management: Set goals and develop plans to meet or exceed monthly repair demand by monitoring on monthly build plan and daily JDA demand plan and supervising the productivity and output of Repair Techs. Ensure agility to meet unforeseen demands. Ensure hourly monitoring of repair progress, troubleshoot reason for delays, and adjust labor and plans, as necessary. Track key performance indicators (KPIs) and operational goals. Ensure all Equipment Repair Orders are accurate, turned in promptly to the Data Entry Clerk, and applicable documents are entered into the Repair Tool the next business day. Provide regular reports to senior management on team performance and operational effectiveness. Lead Lean Daily Management, conduct daily huddles with the entire team to report on current goals and actuals, answer questions, and flow pertinent information to and from all teammates. Team Management: Supervise and support the operational team(s), ensuring the health and safety of all. Responsible for hiring, coaching, performance appraisal, and disciplining subordinate staff. Responsible for scheduling a daily work plan to meet productivity and quality goals. Coordinate shifts and schedules, account for attendance, to ensure sufficient staffing for operational needs. Budget Management: Responsible for own cost center budgets. Track parts and supplies spending, budget forecasting, reporting, and analysis. Team Leadership & Training: Lead, supervise, and support the repair team lead, technicians, data entry clerks, ensuring productivity, efficiency, quality, and safety standards are met. Ensure skills (technical, administrative) are tracked and single points of failure reduced or eliminated to foster a culture according to IDEAL values, teamwork, and continuous improvement. Ensure training of all repair teammates. (i.e. Proper repair protocols according to manufacturer guidelines, standard operating procedures (SOPs), and conduct training sessions to enhance team skills in diagnostics, repairs, and safety procedures.) Ensures all Human Resources, Regulatory, Joint Commission, FDA, and Legal training is completed on time and that all internal and external policies are understood and adhered to. Quality Assurance & Compliance: Ensure products and services meet company's quality standards, customer expectations, and compliance regulations. Ensure quality assurance checks on all products and parts received before stocking or distributing. Conduct final inspections of repaired equipment to verify performance and safety. Ensure quality control and oversee documentation and record-keeping for all repairs/maintenance activities. Support the review and update of the percentage of Operational Verification Procedures. Investigate and implement corrective action on non-conformances. Safety & Maintenance: Actively participate in and/or lead the Safety Committee functions, including weekly and monthly safety checks, to ensure a safe and healthy work environment throughout the facility. Conduct regular safety audits and enforce workplace safety procedures and protocols. Ensure the proper use, functionality, and maintenance of repair tools, equipment, and techniques. Investigate and document safety incidents, injury, property damage, equipment failures and implement corrective actions timely. Cost Control & Process Improvement: Monitor and control repair costs, optimizing resource utilization. Optimize efficiency, identify and implement process improvements to streamline operations, reduce waste, adopt best practices. Lead and facilitate Lean activities, such as Gemba walks, 5S, waste identification, root cause analysis, visual management, process improvement, etc. Share best practices with peers and teammates within the facility and support continuous improvement. Inventory Management: Responsible for timely procurement of goods and tracking inventory movement, including ordering and receiving, track and monitor inventory levels, and ensure proper accounting, safe handling, accurate storage, and distribution of repair materials Maintain a safe, clean, and organized storage areas by ensuring proper labeling, categorization, and placement of inventory. Responsible for implementing and adopting practices for accurate inventory by performing regular stock checks, audits, reconciliations, following regular Cycle Count, and PI timelines. Implement security measures to prevent theft, damage, or loss of inventory. Identify and report discrepancies, losses, damaged goods. Maintain documentation for audits/compliance reviews. Customer Satisfaction and Communication: Proactively manage demand plan and urgent requests. Work with the Planning and Warehouse Team to provide updates on repair status and inventory. Address/resolve customer concerns regarding repair quality or turnaround times. MINIMUM REQUIRED QUALIFICATIONS Education and/or Experience High School Diploma or GED (minimum requirement) 2-5 years of experience in warehouse, logistics, or distribution operations Prior supervisory or leadership experience is preferred Experience with inventory management systems is beneficial SKILLS, KNOWLEDGE AND ABILITIES Build Connections: Problem-solve and influence across teams, project a one-company mindset, connect others to Purpose and Company Goals Embrace Change: Inspire a growth mindset and leverage change as a catalyst for growing the company. Grow Self and Others: Enable and empower growth in yourself and others. Be an Inclusive Leader: Respect and value differences to create an environment for teammates to reach their greatest potential. Deliver Results Today, prepare for the Future: Take ownership, acting with speed and agility to drive results today while staying focused and preparing for evolving market needs and opportunities. Customer/Patient-Focused: Invest time to understand customer's/patients' objectives, then ties activities directly to the achievement of those objectives. Effective Communicator: Writes and speaks clearly, concisely, and transparently with business teammates. Strong Leadership: Passion for health and well-being is deeply found in the desire to help others and be a positive and inspiring role model with proven experience in operations. Requires minimal supervision, thrives as a self-starter who proactively senses and responds to problems and opportunities. Proficiency in software skills (i.e., Microsoft Office Suite, computer programs/applications, developing and interpreting spreadsheets, and inventory software.) Intermediate level mathematical proficiency Certificates, Licenses, Registrations or Professional Designations Knowledge of safety and compliance regulations (OSHA, DOT, FDA, and CHAD). Must meet eligibility requirements for certification with State regulatory agencies of medical oxygen, where required by law. Must maintain training certifications for Medical Gases, Hazmat and PIT Training. MHE/Forklift Certification. Lean skills required. Language Skills English (reading, writing, verbal) PHYSICAL DEMANDS Work Environment: The role may require occasional evening or weekend shifts. This role is 100% onsite required. No remote or hybrid work option. Physical Demands: This is an active position that requires frequent sitting or standing, repetitive wrist motions, grasping, speaking, listening, close vision, color vision, and the ability to adjust focus. It also requires occasional lifting, carrying, walking, climbing, kneeling, bending/stooping, twisting, pulling/pushing, walking, bending, stooping, and reaching above the shoulder. This position also may require the occasional lifting of equipment up to 50 lbs. OTHER INFORMATION The essential duties and responsibilities, physical requirements, and work environment described above are representative of those typically required for this position but may vary depending on staffing and business needs at specific locations. The inclusion or omission of a specific duty or physical requirement is, therefore, not determinative of whether that function is essential to a specific individual's position. Reasonable accommodations will be provided to assist or enable qualified individuals with disabilities to perform essential functions. If you feel this opportunity could be the next step in your career, we encourage you to apply. This position will accept applications on an ongoing basis. Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.
    $65k-70k yearly Auto-Apply 60d+ ago
  • Lead Repair Tech

    Owens & Minor 4.6company rating

    Riverside, CA job

    At Owens & Minor, we are a critical part of the healthcare process. As a Fortune 500 company with 350+ facilities across the US and 22,000 teammates in over 90 countries, we provide integrated technologies, products and services across the full continuum of care. Customers-and their patients-are at the heart of what we do. Our mission is to empower our customers to advance healthcare, and our success starts with our teammates. Owens & Minor teammate benefits include: Medical, dental, and vision insurance, available on first working day 401(k), eligibility after one year of service Employee stock purchase plan Tuition reimbursement ABOUT THE COMPANY Apria Healthcare's mission is to improve the quality of life for our patients at home. We are looking for empathetic, thoughtful, and compassionate people, to meet the needs of our patients. Already an industry leader in healthcare services, we provide home respiratory services and select medical equipment to help our patients sleep better, breathe better, heal faster, and thrive longer. JOB SUMMARY The Repair Technician role is responsible for durable medical equipment repair. The anticipated salary range for this position is $24.06 - $27 (Hourly).The actual compensation offered may vary based on job related factors such as experience, skills, education and location. Shift: Monay-Friday - 6am-2:30pm ESSENTIAL DUTIES AND RESPONSIBILITIES · Repairs and maintains all oxygen and durable medical equipment such as oxygen concentrators, liquid oxygen systems, hospital beds, wheelchairs, suction machines, apnea monitors, home transfill systems and CPAP's. · Ensures equipment is repaired according to manufacturer's guidelines and in an efficient and timely manner to maintain adequate levels of stock in warehouse. · Documents all repairs and maintenance on an Equipment Repair Order and turns in documentation timely. · Monitors parts stock levels and assists in reorder function. · Recommends adjustment of equipment too expensive to repair to Repair Manager. · Performs other related duties as directed by supervisor. SUPERVISORY RESPONSIBILITIES · N/A MINIMUM REQUIRED QUALIFICATIONS Education and/or Experience · High school diploma or general education degree (GED) required. · At least one-year related experience is required. SKILLS, KNOWLEDGE AND ABILITIES · Customer/Patient-Focused: You start with the customer/patient and work backwards. You invest the time and energy to understand the customer's/patients' objectives, then tie all your activities directly to the achievement of those objectives. · Action-Oriented: You thrive as a self-starter who proactively senses and responds to problems and opportunities and requires minimal supervision. · Collaborative: You love teamwork. Your colleagues love having you on the team. You work well across functions and groups. · An Effective Communicator: You write and speak clearly, concisely and with a spirit of partnership. You actively inform and inspire with your messaging. You speak plainly and are transparent with your business colleagues. · Energetic & Passionate: Your passion and energy for health and well-being is deeply founded in your desire to help others and to be a positive role model. · Relationship Builder: You excel in getting people involved and building a network of contacts that allow you to multiply your influence on the organization. Certificates, Licenses, Registrations or Professional Designations · N/A · Computer Skills · Basic computer skills Language Skills · English (reading, writing, verbal) Mathematical Skills · Basic math skills PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently required to sit and use hands to finger, handle, or feel. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 50 pounds. OTHER INFORMATION The essential duties and responsibilities, physical requirements, and work environment described above are representative of those typically required for this position but may vary depending on staffing and business needs at specific locations. The inclusion or omission of a specific duty or physical requirement is, therefore, not determinative of whether that function is essential to a specific individual's position. Reasonable accommodations will be provided to assist or enable qualified individuals with disabilities to perform essential If you feel this opportunity could be the next step in your career, we encourage you to apply. Owens & Minor is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, sex, sexual orientation, genetic information, religion, disability, age, status as a veteran, or any other status prohibited by applicable national, federal, state or local law.
    $24.1-27 hourly Auto-Apply 50d ago
  • Site Quality Head

    Gilead Sciences 4.5company rating

    La Verne, CA job

    At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Site Quality Head (Grade 34) KEY RESPONSIBILITIES: The Executive Director, Site Quality Head is responsible for leading all Quality functions at the pharmaceutical manufacturing site, ensuring compliance with global regulatory standards, driving a culture of quality and continuous improvement, and serving as the primary quality authority for the site. This role is accountable for the strategic direction, operational execution, and leadership of Quality Assurance, Quality Control, and Compliance teams. FOCUS AREAS Quality Leadership & Strategy Develop and execute the site's quality strategy aligned with corporate objectives and regulatory expectations. Serve as the site's quality representative to global quality leadership and regulatory agencies. Compliance & Regulatory Affairs Ensure site-wide compliance with cGMP, FDA, EMA, ICH, and other applicable regulations. Lead regulatory inspections and audits, including preparation, hosting, and response management. Operational Oversight Oversee Quality Assurance (QA), Quality Control (QC), and Compliance functions. Ensure timely release of products, materials, and batches in accordance with quality standards. People & Culture Lead, mentor, and develop a high-performing quality team. Foster a culture of accountability, transparency, and continuous improvement. Risk Management & Decision-Making Serve as the final quality decision-maker for critical quality issues, deviations, and product disposition. Lead risk assessments and implement mitigation strategies. Cross-Functional Collaboration Partner with Manufacturing, Supply Chain, Technical Development to ensure quality is embedded across all site operations. Represent Quality in site leadership forums and strategic initiatives. REQUIREMENTS You have: Experience over a broad set of Quality sub-functions with extensive knowledge of industry best practices and trends. Ability to quickly establish credibility with diverse audiences and be perceived as a leader. Excellent verbal, written, and interpersonal communication skills are required. Must possess excellent influencing skills. Significant in-depth understanding of business objectives and how they translate into quality priorities. Must have the experience and confidence necessary to work with senior executives, and the ability to build rapport with employees at all levels. Must be able to exercise judgment and independently determine and take appropriate action where precedent may not exist. In-depth understanding and application of GMP principles, concepts, practices and standards in the US and internationally. Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories. Demonstrated an ability to develop a vision for Quality functions and have shaped the capabilities of the function to fulfill that vision. Strong hiring and staff development skills, with the ability to motivate and engage individuals. QUALIFICATIONS: 16+ years' experience with a BS OR 14 Years' experience with a MS, MBA, PHD or PharmD in a related field OR 8+ years' experience with an MD degree in related field Prior experience in a Quality Assurance (QA) role, with a solid understanding of QA principles and practices. Extensive knowledge and experience in Biopharmaceutical or Pharmaceutical quality control. Stays ahead of shifting trends in industry. Prior senior leadership experience required. Must think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems. Strong organizational and planning skills. Shows excellent verbal and written communication skills and collaborative interpersonal skills. Gilead Core Values Integrity (Doing What's Right) Inclusion (Encouraging Diversity) Teamwork (Working Together) Excellence (Being Your Best) Accountability (Taking Personal Responsibility) As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ****************** for assistance. The salary range for this position is: $255,425.00 - $330,550.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
    $94k-124k yearly est. Auto-Apply 25d ago
  • Software Engineering Intern

    Danaher 4.6company rating

    Vista, CA job

    Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Leica Biosystems, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. At Leica Biosystems, we're not just shaping the future of cancer diagnostics - we're transforming lives. Our mission of “Advancing Cancer Diagnostics, Improving Lives” is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you're not just taking a job; you're becoming part of a passionate team that knows every moment matters when it comes to cancer. You'll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you'll be inspired each day to stretch, grow, and make an impact. Learn about the Danaher Business System which makes everything possible. The Software Engineering Intern for Leica Biosystems will have an opportunity to learn from Senior Software Engineers and Software Technical Leads to apply computer science, engineering, and mathematical analysis concepts and principles in the development of software for the target application. This position is part of the Digital Pathology Business Unit located in Vista, CA and will be on-site. At Leica Biosystems, our vision is to advance cancer diagnostics and improve lives. You will be a part of the Software Engineering team and report to the Manager, Software Engineering. If you thrive in a fast paced, collaborative environment and want to work to build a world-class organization-read on. In this role, you will have the opportunity to: Support and participate in all phases of the software development life cycle, including requirements analysis, design, implementation, integration, and test of embedded software for real-time control of advanced tactical radio equipment Develop software test procedures, software programs, and related documentation Utilize modeling tools and equipment to establish operating data, conduct experimental tests, and evaluate results Utilize a variety of software languages (i.e., C++, C#, C, Java, Ruby, HTML5, XML, SQL, Perl, Python, Ajax, Qt) on Windows, Linux, mobile platforms, and embedded real time operating systems (VxWorks, Linux, QNX, Integrity, Windows CE, and others for Motorola, Intel, TI, and custom processor designs) Work closely with cross functional members of the engineering organization to develop and evaluate interfaces between hardware and software, and operational performance requirements and design of the overall system Who you are: Pursuing a Bachelor's degree in Software Engineering, Computer Science Information Security or related field Exposure to some of the following: C++, C#, C, Java, Ruby, JEE, HTML5, XML, SQL, Qt, Windows, .NET, Unix, Linux, SOA, RTOS, Real-Time Controls, Wireless, Software Security, Robotics, OOA/OOD, Hadoop, Android, Embedded Systems It would be a plus if you also possess previous experience in: Understanding of agile methodologies and principles. Preferably SCRUM/Kanban Leica Biosystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. The annual salary range OR the hourly range for this role is $25-$35. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit **************** Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:************** or applyassistance@danaher.com.
    $25-35 hourly Auto-Apply 60d+ ago
  • Associate Scientist, Process Development

    Gilead Sciences 4.5company rating

    Oceanside, CA job

    At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description An Associate Scientist in the Biologics Pivotal & Commercial Cell Culture Process Development function will execute cell culture process development laboratory experiments for Gilead biologics entities during pivotal development (phases II/III, commercial). They will also support cell culture process technology development, platform process initiatives, and implementation of cell culture processes in pilot plant and GMP facilities. At a future date this position will relocate to the corporate HQ in Foster City, CA Key Responsibilities Plan and execute experiments to support cell culture process optimization and characterization during pivotal development phases. Support cell culture platform development and pilot plant operations, as needed. Maintain a state-of-the-art cell culture process development laboratory, including equipment upkeep and consumables management. Participates in the equipment maintenance and continued improvement of lab and data handling best practices. Ensure high-quality and timely documentation of data in electronic laboratory notebooks. Collect, analyze, and visualize data from laboratory experiments. Present results of work, interprets data, and draws conclusions regarding presented material and nature of work. Author experimental protocols and reports. Travel as required to support technology transfers and provide oversight at both internal and external manufacturing facilities. Adhere to department budget and all trainings, regulatory compliance, and safety requirements. Basic Qualifications Degree in a relevant scientific discipline (e.g., bioengineering, chemical engineering, biochemical engineering) Bachelor's degree and 4+ years of relevant experience; OR Masters' degree and 2+ years of relevant experience; OR Preferred Qualifications Hands-on laboratory operations experience including shake flasks, high-throughput bioreactors, and bench scale bioreactors Experience with pilot scale bioreactors is a plus Experience in pivotal stage cell culture process development and implementation in GMP facilities is a plus. Excellent communication, technical writing, presentation skills and aptitude for creative problem solving. Demonstrated ability to collaborate, work in a team setting, and influence cross-functionally. The salary range for this position is: $99,705.00 - $129,030.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
    $99.7k-129k yearly Auto-Apply 41d ago
  • Director, R&D Engineering

    Stryker 4.7company rating

    Irvine, CA job

    Work Flexibility: Hybrid or Onsite The Director of Engineering will play a critical leadership role in ensuring seamless product development and transfer to Global Quality Operations (GQO). This leader will be an expert in process characterization of critical processes-developing robust, data-driven methods that anticipate and eliminate transfer risks. The Director will also spearhead Future Technology Development, identifying and shaping patient-centered solutions that address unmet clinical needs, even beyond current technological paradigms.Key ResponsibilitiesProcess Characterization & Product Transfer Establish and lead process characterization frameworks for all critical processes as products are developed, ensuring readiness for seamless transfer to Manufacturing (GQO). Apply and institutionalize methodologies such as: Design of Experiments (DOE) Tolerance Stack-up Analysis Failure Modes & Effects Analysis (FMEA) Process Capability (Cp, Cpk) Studies Statistical Process Control (SPC) Monte Carlo Simulations Root Cause Analysis & Corrective Action methodologies (e.g., 5-Whys, Fishbone) Collaborate cross-functionally with Regulatory, Marketing, Quality, and Manufacturing Engineering to align process development with regulatory requirements and scalability. Develop best practices, playbooks, and training programs for process transfer excellence. Future Technology Development Lead the Future Tech Development portfolio by identifying unmet patient and clinical needs that may not rely solely on advanced technology but can deliver transformative patient impact. Partner with clinicians, patients, and external innovation networks to surface and evaluate future opportunities. Translate unmet needs into clear problem statements, guiding early feasibility assessments and exploratory work. Develop pathways for future technology projects, from concept validation through to integration into strategic pipelines. Champion physician/patient-first innovation that balances clinical benefit, usability, and access with technical feasibility. Leadership & Strategy Build, mentor, and inspire a high-performing engineering team with expertise in process characterization, technology exploration, and patient-centered design. Provide technical and strategic guidance across multiple product lines and development stages. Influence organizational decision-making by presenting clear, data-driven insights and future technology opportunities. Drive a culture of rigor, innovation, and execution excellence across R&D and GQO interfaces. Competencies Strategic Thinker: Balances near-term execution with long-term innovation. Technical Rigor: Expert in data-driven methods for robust product and process development. Collaborative Leader: Builds bridges across Regulatory, Quality, Operations, and external stakeholders. Innovator: Identifies unmet needs and translates them into tangible patient benefits. Physician/Patient-Centric: Anchors all decision-making on improving outcomes and access for patients. Minimum Qualifications (Required) Bachelor of Science degree or Higher in Engineering or applicable technical field. 12+ years applicable experience, with 6+ years direct people management experience preferred. Applicable industry experience may be considered in lieu of a degree Advanced degree in Mechanical Engineering, Biomedical Engineering, or related discipline; PhD preferred. Required: 12+ years of progressive experience in medical devices, biotech, or related regulated industries. Deep expertise in process characterization methodologies, with proven success in ensuring smooth transfer of products from R&D to Manufacturing. Strong background in statistical methods, experimental design, and process validation. Demonstrated ability to lead cross-functional engineering teams and influence senior stakeholders. Strong understanding of regulatory frameworks (FDA, ISO, EU MDR) and design control requirements. Track record of delivering patient-centered innovation, not limited to high-tech but also practical, unmet-need-driven solutions. Preferred: Experience with Global Quality Operations (GQO) or equivalent manufacturing integration functions. Prior leadership of Future Technology/Strategic Innovation portfolios. Exposure to multiple therapeutic areas, devices, and global markets. Technical Skills: Broad and comprehensive understanding of, experience in, and ability to mentor in one or more technical/functional disciplines. $171,900 - $263,300 salary plus bonus eligible + generally eligible for short-term and long-term financial incentives + benefits. Individual pay is based on skills, experience, and other relevant factors. Travel Percentage: 20%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
    $171.9k-263.3k yearly Auto-Apply 60d ago
  • Validation Engineer II

    Gilead Sciences 4.5company rating

    La Verne, CA job

    At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Key Responsibilities Contribute to validation projects by developing schedules, master plans, impact assessments, risk assessments, validation protocols, reports, and requirements trace matrices for complex systems supporting clinical and commercial manufacturing. Perform Computer System Validation (CSV) elements for equipment, utility systems, facilities, processes, and automation systems. Author validation master plans, risk assessment documents, protocols, technical reports, and requirement trace matrices. Embed data integrity principles into daily operations and validation programs. Coordinate validation activities with cross-functional teams to ensure timely and budget-conscious execution. Foster collaborative relationships across teams to deliver high-performance validation programs. Identify and drive continuous improvement initiatives for compliant and lean sustainable solutions. Review project-related documents and data from vendors, validation teams, and project teams. Represent the validation department on cross-functional project teams. Basic Qualifications Bachelor's degree in science or a related field with 4+ years of relevant experience, OR Master's degree (MS or MBA) with 2+ years of relevant experience. Understanding and application of validation principles, including GAMP, Part 11, Data Integrity, and Annex 11. Proficiency in current Good Manufacturing Practices (GMPs). Working knowledge of equipment, systems, and industry practices. Strong verbal, technical writing, and interpersonal communication skills. Ability to resolve moderately complex validation issues with limited supervision. Proficiency in Microsoft Office applications. Preferred Qualifications Experience using Root Cause Analysis tools. Operational excellence mindset and experience driving continuous improvement initiatives. Experience coordinating cross-functional validation projects. The salary range for this position is: $99,705.00 - $129,030.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
    $99.7k-129k yearly Auto-Apply 60d+ ago
  • Business Solutions Manager

    Edwards Lifesciences 4.6company rating

    Irvine, CA job

    Innovation starts from the heart. At Edwards Lifesciences, we're dedicated to developing ground-breaking technologies with a genuine impact on patients' lives. At the core of this commitment is our investment in cutting-edge information technology. This supports our innovation and collaboration on a global scale, enabling our diverse teams to optimize both efficiency and success. As part of our IT team, your expertise and commitment will help facilitate our patient-focused mission by developing and enhancing technological solutions. At Edwards Lifesciences, we're committed to operating with honesty, openness, and fairness. Compliance with the highest levels of integrity is vital to building and maintaining the many trusted relationships that sustain our reputation and credibility. Your dedication to operational excellence will ensure employee business practices meet Edwards' high ethical standards and continue to enable us to transform patient lives around the world. The manager for Digital Quality and Compliance will be responsible for managing the sustainability aspects of the ePAC Program. This role will collaborate cross functionally with various areas of the organizations to develop a deep understanding of how Product Distribution Compliance is enabling Marketing, Regulatory, Labelling, Supply Chain and Quality Processes. The successful individual must have a combination of analytical skills, project management understanding, and business acumen with an ability to think enterprise-wide and support global operations. The manager would be comfortable with interacting with upper management and enforcing governance and providing expertise in development of technical solutions to optimize processes and systems. How you will make an impact: • Oversee the reengineering and optimization of business processes and systems. Act as a Subject Matter Expert (SME) in business processes in the area of responsibility. • Configure and test systems to execute features, integration, and reporting • Evaluate and validate functional business requirements against business needs. • Translate the needs of business and articulate the functional design to meet requirements • Manage and monitor global system enhancement requests for ePAC Program. • Identify root causes and provide guidance for resolutions for testing and validation of processes and systems including perform complex root cause analysis and troubleshoot business processes including testing and researching data integrity/accuracy • Serve as liaison between team members and stakeholders in the area of responsibility. Lead efforts to reengineer and optimize business processes and systems. • Provide design and architecture guidance to project teams to execute tactical projects / initiatives • Identify and recommend innovations that significantly enhance efficiency and effectiveness of business processes • Other incidental duties What you'll need (Required): • Bachelor's degree in a related field (or equivalent) and a minimum 8 years of relevant experience, or an equivalent combination of education and experience as defined by Edwards criteria. What else we look for (Preferred): • Stay current with latest platform features • Project management skills • Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives • Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards • Extensive knowledge in at least discipline (e.g. Analysis, Design, Development, QA/QC, etc.) • Substantial technical knowledge with expertise in at least one technical language or data management system (e.g. Oracle, SQL Server.) • Ability to learn and map platform ecosystem, business processes and integration points. • Strict attention to detail • Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization • Ability to manage competing priorities in a fast paced environment • Represents leadership on sections of projects within a specific area interfacing with project managers and team • Consult in project setting within specific sections of area • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $118,000 to $167,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
    $118k-167k yearly Auto-Apply 21d ago
  • IT Compliance & Audit Intern

    Danaher 4.6company rating

    Brea, CA job

    Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making-we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the Danaher Business System which makes everything possible. As an IT Compliance & Audit Intern, you will be part of the Governance, Information Systems & Compliance (GISC) team and reporting to the Senior Manager, IT Compliance & Audit. You will be assisting with compliance activities and auditing of IT systems. In this role, you will have the opportunity to: Assist Beckman in meeting corporate regulatory requirements (such as SOx, PCI-DSS, ISO/IEC 27001, and other regulatory standards) Perform IT audits on behalf of Beckman Coulter's to ensure the design and operating effectiveness of controls. Enhance Beckman Coulter's digital transformation in maturing the IT compliance environment through implementation of solutions using data and emerging technologies. The essential requirements of the job include. Major in Computer Information Systems, Management Information Systems or, Accounting with a high-interest in technology. Basic understanding of computer networks, operating systems, and cybersecuity principles, and database systems. Strong analytical and problem-solving skills. High familiarity with Microsoft Office Suite (Word, Excel, PowerPoint). Excellent attention to detail and organizational skills. Good verbal and written communication skills. Ability to work effectively both independently and as part of a team. Proactive and eager to ask questions and learn new technologies. Any exposure to Active Directory, basic scripting (e.g., SQL, PowerShell) is a plus, but not required. Enthusiasm for learning about IT Compliance such as SOx, PCI, and other regulatory compliance. The hourly range for this role is $30.00. This is the rate that we in good faith believe is the rate of compensation for this role at the time of this posting. Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit **************** Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:************** or applyassistance@danaher.com.
    $30 hourly Auto-Apply 60d+ ago
  • Manufacturing Engineer II

    Gilead Sciences 4.5company rating

    La Verne, CA job

    At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Key Responsibilities Manage standards, methods, and procedures for the design, modification, and maintenance of manufacturing and packaging equipment and processes. Plan, execute, and track a variety of engineering projects to support operational efficiency and compliance. Coordinate cross-functional efforts to resolve issues related to manufacturing, packaging, and maintenance in both project and day-to-day operations. Contribute to the development of departmental strategy and continuous improvement initiatives. Participate in internal and external audits, including vendor and contract manufacturer assessments. Implement systems for tracking project progress and compile technical performance metrics. Maintain and develop engineering systems that support equipment uptime and reliability. Basic Qualifications BS or BA in Engineering or a related field with at least 4 years of relevant experience, or MA or MBA with at least 2 years of relevant experience. Demonstrated understanding and application of process engineering principles and practices. Proficiency in current Good Manufacturing Practices (GMPs) and safety regulations. Strong verbal, written, and interpersonal communication skills. Proficient in Microsoft Office applications. Preferred Qualifications Prior experience in the biotech or pharmaceutical industry. Experience in engineering within highly regulated manufacturing environments. Knowledge of pharmaceutical packaging, process manufacturing, and performance metrics such as OEE and MTBF. Familiarity with root cause failure analysis and continuous improvement methodologies. The salary range for this position is: $99,705.00 - $129,030.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: ****************************************************************** * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
    $99.7k-129k yearly Auto-Apply 3d ago

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