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  • Director, Quality Assurance

    Cirsium Biosciences

    Quality manager job in San Diego, CA

    Cirsium Biosciences is creating the next generation of manufacturing technologies for viral vector production. Our novel plant-based platform solves the existing problems of speed, flexibility, scalability, and safety in viral vector manufacturing while dramatically reducing production costs. Our goal is to enable global and equitable access to life-changing genetic therapies. Position Overview We are seeking a highly collaborative Director, Quality Assurance to join and lead the QA function for our growing organization. This strategic role will oversee all aspects of Quality, including the development, implementation, and management of GxP (cGMP, GCP, and GLP) quality systems. Our ideal candidate should have a strong knowledge of relevant regulations and be able to manage and work cross‑functionally to ensure compliance of Cirsium's ongoing development programs with local, state and federal requirements. This position will support developing a culture of quality, ensuring compliance with regulatory requirements, driving continuous improvement in quality systems, supporting the successful development, manufacturing, and commercialization of our unique products. Key responsibilities Assist with developing, implementing, and maintaining GxP compliant quality systems and processes to ensure compliance with FDA, EMA, ICH, and global competent authority regulations and industry guidance Co- lead quality audits, risk assessments, and investigations, ensuring timely resolution of quality issues. Work with the company's external suppliers and contract organizations to ensure consistent quality and compliance. Prepare for and manage inspections by regulatory agencies and commercial partners, serving as a liaison between the Company and auditors, including reporting and follow-up to any finding Work on qualification and validation plans, assure proper batch releases and disposition. Oversee resolution of any product concerns, including investigation, tracking and corrective action plans (CAPA). Provide quality input on contracts and serve as a point person for negotiations of quality agreements. Champion a culture of quality and continuous improvement across manufacturing and development operations. Qualifications Bachelor's degree in biological sciences or related field, with a minimum of 7 or more years experience in Quality Assurance or related fields within the pharmaceutical or biotechnology industry Extensive knowledge of GxP (GMP, GLP, and GCP) regulations and guidelines, including FDA, EMA, and ICH requirements Demonstrated hands‑on experience working on complex projects. In‑depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC. Strong partnering and communication skills required, as well as project management skills. Must be focused on working collaboratively and within our values of: Data rules, All‑in, Own it (Accountable), Caring and Humble. Ability to work effectively in a collaborative, fast‑paced environment. Strong analytical skills, excellent problem‑solving skills, and innovative thinking for sustainable practices. Strong organizational and time‑management skills with the ability to handle multiple projects. Excellent leadership and communication skills, and the ability to work in a collaborative, fast‑paced environment. Generous PTO Health Insurance & Health Savings Account Vision Insurance Employee Assistance Program (EAP) Stock Options Professional Development Opportunities 401(k) Plan Life & AD&D Insurance And More... Cirsium Biosciences is an emerging company located in San Diego, California. We offer highly competitive compensation and employee programs, including comprehensive health, dental and vision plans, generous time off, and equity in our early‑stage company. We are dedicated to fostering a workplace that keeps our team inspired and engaged. We offer an inclusive company culture where employees feel respected and valued. Cirsium Biosciences is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation, veteran status, or any other protected categories. #J-18808-Ljbffr
    $131k-214k yearly est. 3d ago
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  • Director, Quality Assurance GCP

    Crinetics Pharmaceuticals, Inc. 3.9company rating

    Quality manager job in San Diego, CA

    Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others The Director, Quality Assurance (GCP) oversees the development, implementation, maintenance, and performance of GCP Quality Assurance systems both within company and external vendors. The Director will execute and/or ensure proper oversight of the GCP QA audit program management, clinical operations phase 1 to phase 4 study team support, regulatory inspections, and GCP QA infrastructure development.**ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:**These may include but are not limited to:General* Provide GCP quality assurance strategy and oversight of QA GCP operations* Ensures that clinical trials and research activities adhere to regulatory requirements, industry standards, and internal policies* Develop and implement risk management strategies to identify, assess, and mitigate risks* Drive effective initiatives that foster a culture of quality and continuous improvement* Successfully collaborate on multiple projects with cross-functional stakeholders* Lead investigations of significant complexity* Prepare and present to executive management* Manage, lead, and mentor quality assurance team members; lead cross-functional teams on compliance projects Audit Management* Develop a plan with CROs for clinical sites' audit execution* Manage clinical site, TMF, and GCP and GLP vendor audit activities* Generate and/or review and approve overall GCP QA audit plans and schedules* Generate and/or review and approve audit trend reports* Execute the GCP QA audit program to ensure that processes and systems are adequate for communicating, addressing, and preventing identified GCP compliance issues and trends Study Team Support & Issue Escalation Management* Represent QA at program-wide (e.g., study team or governance) meetings and provide GCP guidance and feedback* Serve as point of escalation for GCP compliance issues identified by clinical study teams or QA leads, and responsible for informing the head of QA and Management, as required* Manage quality events, CAPAs, and deviations* Collaborate with cross-functional teams (Clinical Operations, Clinical Research, Regulatory, etc.) to embed quality by design in clinical programs.* Provide guidance and support to Trial Master File activities Quality Systems / Inspections / Infrastructure* Ensure adequate systems and controls are in place for GCP compliance* Identify and address quality systems gaps, including internal processes and personnel GCP training* Execute the review of GCP SOP tracking and status reports to ensure timely review and development of SOPs* Author, review, or revise SOPs related to clinical and non-clinical studies* Develop and provide GCP training* Support regulatory inspection activities* and GCP inspection readiness activities* Prepare internal team, clinical sites, and vendors for inspection readiness* Thoroughly review clinical study documents* Perform breach assessments* Oversee quality vendor management and governance for GCP and GLP vendors* Review Quality Agreements to ensure clear delineation of responsibilities and compliance expectations between the sponsor and the vendor* Contribute and present GCP quality events and metrics at the Quality Management Review meeting* Support other Quality Assurance and Quality Systems activities* Other duties as assigned.**Education and Experience**Required:* Minimum Bachelor's degree in a science discipline and at least 12 years' experience in a QA function within the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered)* Minimum of 8 years of working in a GCP QA function* Previous experience leading inspection readiness and audits* Thorough understanding of FDA, EU and local regulations, as well as understanding of ICH guidelines* Hands-on experience in developing and implementing GCP procedures* Strong working knowledge of GCP and GLP regulations* Proven ability to cultivate and develop relationships with cross functional teams and vendors* Demonstrated leadership ability to identify, manage and develop QA teams* Must be able to make critical and strategic decisions based on risk-assessments* Capable of managing multiple projects simultaneously* Excellent communication and listening skills Preferred:* Auditing certification is a plus**Physical Demands and Work Environment:**Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.**Travel:**You may be required to travel for up to 10% of your time.**The Anticipated Base Salary Range: $1****76,000 - $220,000***In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.*The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.**Equal Opportunity Employer:**Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.**Vaccination requirement:**Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone #J-18808-Ljbffr
    $220k yearly 3d ago
  • Director, Quality Engineering - MedTech Leadership

    BD Mexico

    Quality manager job in San Diego, CA

    A global medical technology company in San Diego is seeking a Director of Quality Engineering to lead the quality engineering function. This role involves ensuring that medical devices meet regulatory compliance and safety standards, mentoring a team of engineers, and developing a comprehensive quality strategy. The ideal candidate will have extensive experience in quality engineering within the medical device industry and expertise in regulatory compliance. Join a workplace that fosters growth, innovation, and collaboration. #J-18808-Ljbffr
    $145k-224k yearly est. 3d ago
  • Design Quality Engineer II

    Actalent

    Quality manager job in Irvine, CA

    We are seeking an experienced Design Quality Engineer II to support a long-term new product development initiative extending through February 2027. This role plays a critical part in ensuring design quality, regulatory compliance, and risk management throughout the medical device product lifecycle. The ideal candidate brings a strong foundation in design controls, verification and validation, and cross‐functional collaboration within a regulated medical device environment. This position partners closely with Product Development, Advanced Operations, Regulatory Affairs, Manufacturing, and Marketing to ensure products meet the highest standards of safety, performance, and quality from concept through commercialization. About the Client You Will Support You will be supporting a rapidly growing, innovation-driven medical device manufacturer focused on minimally invasive, life‐saving technologies. The organization is dedicated to improving patient outcomes through thoughtful design, rigorous engineering, and uncompromising quality standards. Operating in a highly regulated global environment, the company combines a fast-paced, entrepreneurial spirit with a deep commitment to clinical excellence, regulatory compliance, and continuous improvement. The culture values technical rigor, collaboration, and accountability, empowering team members to influence key decisions and make a measurable impact on products that directly improve patient lives. Key Responsibilities Develop quality assurance documentation to support new product development and global regulatory submissions Maintain and improve quality system processes related to design controls, identifying and correcting deficiencies Actively engage in design, development, manufacturing, and risk management activities across multiple projects Participate in design reviews, identifying risks and tracking mitigation actions throughout development Support the definition of design verification and validation testing requirements Complete final V&V reports with appropriate statistical analysis and graphical representation Promote efficient, compliant, and risk‐based testing strategies Partner with Advanced Operations to support development of scalable manufacturing processes Apply statistical analysis and structured problem-solving techniques to define acceptance criteria and resolve quality issues Develop, review, and approve inspection plans, routers, and engineering drawings Support design transfer activities to internal and external manufacturing partners Evaluate predicate devices to identify quality risks impacting new product development Analyze and define critical quality attributes using formal risk analysis methodologies Participate in early post‐launch market feedback activities and address initial quality concerns Lead design and product risk management activities, including development of risk management plans and reports Essential Qualifications Experience across the medical device product development lifecycle, including design controls, risk management, and verification and validation Applied knowledge of Advanced Quality tools such as FMEA, GD&T, Root Cause Analysis, and Mistake Proofing (Poka‐Yoke) Ability to read and interpret engineering and CAD drawings Experience interfacing with regulatory bodies (FDA, international ministries of health, notified bodies) Thorough understanding of U.S. and international medical device regulations Strong understanding of quality system principles including CAPA, audits, and statistical methods Proven project management skills with the ability to manage multiple priorities in parallel Ability to effectively advocate for product excellence and patient safety Strong cross‐functional collaboration skills across engineering, operations, regulatory, and commercial teams Excellent written, verbal, and interpersonal communication skills Critical and creative problem‐solving capabilities Ability to operate effectively within a matrixed organization Comfortable working independently with minimal supervision Proficiency with data analysis tools such as Minitab or equivalent Additional Qualifications * Experience working in compliance risk or high‐visibility regulatory situations * Prior involvement supporting design transfer or commercialization activities Work Environment & Benefits Contract assignment through February 2027 3 weeks of paid time off and 10 paid holidays Highly collaborative, cross‐functional environment Exposure to innovative, market‐leading medical device technologies Emphasis on analytical thinking, accountability, and continuous improvement Encouragement of independent thought and proactive problem-solving Job Type & Location This is a Contract position based out of Irvine, CA. Pay and Benefits The pay range for this position is $55.00 - $65.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Irvine,CA. Application Deadline This position is anticipated to close on Jan 31, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
    $55-65 hourly 3d ago
  • Quality Engineer

    Baxter 4.2company rating

    Quality manager job in Irvine, CA

    This is where your work makes a difference. At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job-you will find purpose and pride. Your Role Lead product and process improvement & NCR/CAPA projects with minimal supervision, managing cross-functional teams to timely and effective closure. · Apply problem-solving methodology (e.g. Lean & Six Sigma) to arrive at robust and practical solutions in an expedited manner. · Perform root cause investigation analysis and data trending for NCR/CAPA. · Manage project documentation in "TrackWise" system in compliance with Baxter practices and procedures. · Perform monitoring of metrics in support of site and company goals and objectives. · Support other teams in Investigation of customer complaints or internal events. Your Team Baxter is focused on saving and sustaining lives by manufacturing high-quality products. We strive to create quality products for our customers each day. Delivering life-saving products is about getting them right, and attention to detail is how we make sure we meet that challenge. We are a team that supports each other throughout each day. Working together in a supportive and open culture makes our processes evolve for the better and engages our workforce. What You'll Be Doing Apply sound engineering practices and problem-solving methodology (e.g. Lean & Six Sigma) to arrive at robust and practical solutions in an expedited manner. Act independently with minimal supervision to investigate and analyze process or product issues and design improvement suggestions based on recent technical knowledge. Perform root cause investigation analysis and document within the quality system as appropriate (NCR/CAPA). Design and perform routine testing, project experiments, analysis of data and reports results. Perform engineering studies on new equipment to determine proper settings, control points, etc. including data gathering during start up and test batches. Work with manufacturing and other functional groups on manufacturing regulatory compliance issues. Write, execute, and develop report for validation activities, including qualification protocols. Perform work assignments within production department that include training, technical support and/or process trouble shooting support. Lead product and process improvement & NCR/CAPA projects with minimal supervision, managing cross-functional teams to timely and effective closure. Serve as CAPA Site Representative and Subject Matter Expert (SME) and provide training to local employees as needed on relevant area(s). What You'll Bring Understanding of engineering principles in various engineering disciplines related to medical device manufacturing. Bachelor's degree in engineering. 1 - 3 years of experience. Demonstrated ability to effectively run projects and direct the activities associated with those systems in regulated environment. Strong command of problem-solving techniques and ability to coach others in their application. Must be able to write clearly and informatively, present numerical data effectively, able to read and interpret written information. Must have strong verbal and written communication skills, documentation practices (cGDPs), be self-motivated and possess strong interpersonal skills. Ability to work collaboratively in a team-oriented environment. Working knowledge of FDA quality system regulations. Working knowledge of Quality Management System. We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $72,000 - $99,000 annually. The estimated salary is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview. Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. US Benefits at Baxter (except for Puerto Rico) This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Know Your Rights: Workplace Discrimination is Illegal Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
    $72k-99k yearly 6d ago
  • Quality Engineer II

    BALT Group

    Quality manager job in Irvine, CA

    About Balt Our purpose is to improve the lives of 150,000 patients in 2026. Our story Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the world, and we have 13 offices in 11 countries - and counting. We introduced one of the first neurovascular intervention devices in 1977 and now offer the world's broadest portfolio of medical devices for stroke. As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space. We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives. Why Join Balt? Join a passionate team, dedicated to making a difference. Working at Balt means giving meaning to your work! Pride is a strong part of our identity. We are a close-knit team, with strong mission, vision and values that guide our day-to-day. Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success. No matter the country, we take care of you. Would you like to be part of our story? Don't hesitate, come and join us! About this opportunity - Quality Engineer II Description The Operations Quality Engineer II will be responsible for supporting production quality, the transfer of neurovascular products to the production environment, and supplier quality activities. This engineer will be expected to work directly with production and suppliers while being provided moderate levels of support/guidance from other engineers and their manager to complete tasks. This position will have the responsibility to support and continuously improve current manufacturing and supplier quality processes through technical and process innovation for the manufacture of neurovascular medical devices that save patient lives. Job Responsibilities Daily tasks: Production support of existing products/processes and sustaining work Support the manufacturing organization to facilitate efficient operations, optimize existing processes, and ensure that production goals are met. Develop process and procedure updates for increased efficiency, quality, and productivity. Work with Manufacturing Engineering to correct equipment problems or process parameters that produce non-conforming products, low yields, or product quality issues. Analyzes nonconforming product, process, and material issues supported by use of root cause tools to drive corrective actions. Own NCMR and CAPA investigations and corrections/corrective actions Support requests for new supplier onboarding and offboarding Complete tasks related to supplier changes and management of existing suppliers Spend significant portions of time in the production environment. Work closely with production operators and Quality Control inspectors in the production environment. Provide feedback to Quality, Operations, Engineering and R&D on quality issues. Detail oriented review and approval documentation in support of production and process improvement Additional Tasks: Development project work - design transfer, commercialization of new products, and site manufacturing transfers Interface with New Product Development team in design control projects to integrate new products or processes into the existing manufacturing area. Process development, validation and verification work is required - knowledge of Process Validation Plans, IQ, OQ, PQ, software validation, test method validation/gage R&R, a clear understanding of FDA's QMSR and cGMP, and a good understanding in the application of statistics to process analysis and improvement. Communicate with suppliers to address quality concerns and resolves issues. Maintain and develop processes and procedures by writing standard work instructions for operations involved with production and quality. Qualification Requirements Bachelor's degreerequired, preferably in engineering or science discipline. 2+ years as an Engineer in a related field. Medical device or pharmaceutical experience. Process and Equipment qualification knowledge. Statistical analysis skill set. Highly Desired Qualifications Class II and III implantable medical device experience with focus on neurovascular devices. Experience creating and implementing new production line layouts. Minitab proficiency. Strong background in medical device components using metals, plastics, extrusion, and/or adhesives. A demonstrated ability to plan and run projects. Skills Required: Keen attention to detail when reviewing documentation and processes. Solid technical writing ability Comfortable working independently and cross-functionally as part of a team. Comfortable communicating with a wide range of people (production, regulatory, management, suppliers, and others) General understanding of Risk Management, including design, use, and process FMEAs as well as a basic understanding of Severity, Occurrence, and Risk Mitigation and their impact on product/process controls. General understanding of Process Validation (OQ/PQ) and ability to develop test protocols/report to meet FDA and ISO requirements for class II and class III devices. General understanding of CAPA process and root cause analysis tools and how to use them Ability to develop/draft manufacturing documentation (Manufacturing Procedures, Engineering Drawings, BOM, Work Orders). General familiarity with design control requirements and V&V testing for new product designs. Effectiveness with lab equipment, assembly tools, and measurement devices. Basic understanding of statistical analysis techniques for identifying process capability and equivalence testing. Development and qualification of tooling/ equipment (IQ/OQ, support, design). Knowledge of computer applications (i.e.: Microsoft Project, Word, Excel, PowerPoint, Windows, Visio, etc.) required. Highly Desired Qualifications: Experience with catheters, coils, or stents device manufacturing processes and equipment. Test Method Validation and/or Measurement System Analysis experience, including Gage R&Rs and Attribute Agreement analysis Process background (development, capability, optimization, validation) within the medical device industry. Equipment and tooling design and optimization using DFM and Six Sigma principles. Leading project teams tasked with new product/process development and the successful transfer into manufacturing. Knowledge to develop and improve manufacturing processes from concept to commercialization including characterization, validation and cost/capacity analysis. Application of statistical and analytical methods for process development, optimization and control such as SPC, SQC, and DOE. Knowledge of SolidWorks for both part and fixturing/equipment design. Work Environment Working conditions are normal for an office environment. Extended computer usage. Standard PPE gowning requirement for cleanroom activities is required. Moderate lifting Extended periods of walking or standing Microscope usage The above information on this description have been designed to indicate the general nature of work performed by employees within this position. It is not a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Balt Group is an Equal Employment Opportunity employer. More information please go to ***************** Please be aware of a current job offer scam perpetrated through the use of the internet. The scammers frequently misappropriate and use a company's log and photos to give the appearance of legitimacy. The scam preys upon those seeking employment and uses false and fraudulent offers of employment with employers, such as Balt Inc to steal from the victims. Balt believes that one of the best ways to put a stop to this scam is to make sure you are aware of it. Balt's job recruitment process involves live communication: in person, telephone, and/or video interviews in most cases. #LI-FW1 Pay Range $85,000-$95,000 USD
    $85k-95k yearly 7d ago
  • Air Quality Engineer/Scientist (Environmental Compliance Specialist)

    Yorke Engineering, LLC

    Quality manager job in Riverside, CA

    Join Yorke Engineering, LLC, an Environmental Consulting leader in California that implements Environmental Engineering and Compliance solutions for our clients throughout California. Our mission is to solve environmental compliance problems for industrial and governmental/infrastructure facilities. We are a growing and dynamic organization of highly respected professionals. Yorke Engineering, LLC has assisted over 1,900 client organizations with their Air Quality and Environmental Compliance, Engineering, and Permitting needs. Our philosophy is to efficiently help government and industrial customers with the complex array of environmental laws and regulations. From simple permits to complex agency negotiations, from small companies to the largest of California's organizations, Yorke successfully solves our clients' Air Quality and Environmental challenges. Our team has over 1,000 years of combined environmental experience and consists of engineers and scientists that specialize in Air Quality, Waste, Water, CEQA, Safety, and Industrial Hygiene. We are looking for a sharp Air Quality Engineer / Scientist (Environmental Permitting and Compliance Specialist) to join our team in any of our Southern CA offices (Diamond Bar, Long Beach, Los Angeles, San Juan Capistrano, San Diego, Ventura, or Riverside) during our normal business hours. We offer competitive salaries, a full benefits package including Paid Time Off, Holidays, Full Medical/Dental/Vision, along with a 401k program with a generous company match. Position Summary: The Air Quality Engineer / Scientist (Environmental Permitting and Compliance Specialist) performs professional engineering work, executing the compliance and permitting functions in relation to Air Quality Regulations and Compliance. This candidate will be reviewing processes and equipment, analyzing permit-related technical and regulatory issues, and communicating those analyses within Yorke, the client organization, with government agencies and with the public at large. The work is challenging, broad in scope, and variable from project to project. The position involves effective communication, decision-making, and time management. The candidate performs other duties as required or assigned. The candidate qualifications we are seeking include: 5-15 years of work experience in the Air Quality and/or Environmental industry in an engineering role (preferably in a consulting environment); Experience as an active team member in the environmental services industry as a consultant focusing on: Process and equipment review; Air quality permitting under SCAQMD, and other Air Districts, including Title V permitting; RECLAIM implementation and reporting; Annual Emissions Reporting; Air Dispersion Modeling; Air Quality Assessments including Data Analysis and Emission Inventories; General Air Quality Compliance for facilities in CA, including problem solving. Ability to be an active team member on project teams towards project completion within project scope, budget and schedule and ensure quality work product and deliverables; Ability to work with clients, staff, and regulators through effective communication and expertise by fostering a collaborative environment without losing focus of quality; Proven track record or desire to engage in successful regulatory work in dealing with the SCAQMD, EPA, CARB and/or other similar regulatory agencies; Experience or desire to work on-site at client facilities; Prepare reports and submissions in timely manner; Experience with handling highly technical data and technical data interpretation; Highly motivated to continue working in Air Quality environmental field and expand their knowledge and experience; CA Regulatory/Compliance experience is required. Job Requirements: B.S or M.S. degree in Chemical Engineering, Environmental Engineering, or Mechanical Engineering, or other relevant technical degrees from an accredited college (minimum GPA of 3.0); Ability to work collaboratively in a team fashion, handle several projects at once, prioritize work, and work efficiently; Desire to learn or developing technical expertise in environmental rules and regulations; Excellent oral and written communications skills; Experience in conflict resolution and crisis management; Track record of successful analysis, interpretation, and application of rules and regulations towards practical solutions; Ability to think critically and develop solutions; Software Knowledge: Strong Microsoft Excel, Word, Outlook, and Powerpoint skills (required); Microsoft 365 Applications, including Sharepoint (a plus) EIT, CPP or P.E. (a plus).
    $76k-102k yearly est. 1d ago
  • Fuels Quality Control Manager

    GSI Technology 4.6company rating

    Quality manager job in San Diego, CA

    Description JOB DESCRIPTION/SUMMARY The CQC Manager will be assigned to Department of Defense (DoD) construction project(s) located in various regions. This individual will be responsible for all aspects of quality control (QC) and must be onsite during all phases of the construction work. While at the jobsite, the CQC Manager works with the customer and other contractor staff to ensure QC objectives are met in accordance with the contract requirements and high standards of service delivery are maintained. DUTIES AND RESPONSIBILITIES · Prepare and update the QC Plan.· Attend coordination meetings with the Client, subcontractors, and vendors.· Implement the “Three Phases of Control” for all definable features of work.· Perform inspections to ensure work is completed in compliance with contract requirements.· Stop work that does not comply with the contract plans and specifications and direct the removal and replacement of any defective work.· Prepare and submit daily quality control reports.· Conduct weekly QC meetings at the jobsite. • Oversee the review and approval of design and construction submittals.· Ensure As-Built drawings are updated daily.· Coordinate onsite and offsite testing. Maintain a testing log.· Review invoices prior to approval to ensure all relevant work has been completed in accordance with the contract requirements.· Perform punch-list and pre-final inspections.· Perform other duties as requested by supervisors and senior level managers in support of successful performance on all projects.MINIMUM QUALIFICATIONS, SKILLS, AND EDUCATIONAL REQUIREMENTS A Bachelor's of Science degree from an accredited school in engineering or sciences with a minimum of seven (7) years' experience (within the last ten (10) years), as a Superintendent, Project Manager, or Project Engineer and at least five (5) years field experience as a CQC Manager with repairs to DoD petroleum, oil, and lubricants (POL) facilities, tank rehabilitation, tank cleaning and repairs and emergency inspection Familiar with requirements of USACE EM-385-1-1, and experience in the areas of hazard identification, safety compliance, and sustainability Knowledge and experience with POL industry standards including API Std 650, API Std 653, API RP 2016, and API Std 2015 and procedures an applicable DoD criterion Completion of course entitled Construction Quality Management for Contractors must be completed prior to fieldwork INTER-PERSONAL RELATIONSHIPS Must work effectively with employees, subcontractors, and clients at all levels. WORKING CONDITIONS The position requires working at the construction job site for extended periods of time. The position may require working during weekends and extended hours in order to meet deadlines. We are committed to a merit-based hiring process that values individual skills, qualifications, and performance. Our hiring practices comply with all applicable federal, state, and executive orders, including the recent Executive Order on Equal Opportunity Hiring.
    $78k-111k yearly est. Auto-Apply 6h ago
  • Program Manager Quality Improvement

    Apidel Technologies 4.1company rating

    Quality manager job in Newport Beach, CA

    Job Description Responsible for establishing and continuing eective quality improvement eorts to achieve organizational performance goals and national top decile performance in clinical excellence. Quality improvements may be small or large scale and are in alignment with s strategic goals for example, addressing 30-day readmissions and mortality reduction. The Quality Improvement Manager may apply Lean, Six Sigma, and other quality improvement methodologies to deliver results. Job Responsibilities: Coaches and trains teams in the utilization of improvement tools and implementation of improvements. Manages plans and develops guidelines, process measures, targets, and standards for monitoring and measuring results to deliver on goals. Interacts daily with leaders, to identify, dene, and manage opportunities to improve quality while helping create a strategic approach to produce and establish extraordinary improvement. The Program Manager Quality Improvement collaborates to lead and organize eorts for continuous clinical improvement. Skills: Required Skills & Experience: Advanced training or experience in performing statistical, financial and strategic analysis Five years experience in performance/process improvement projects including but not limited to Lean, Six Sigma methodologies Demonstrated performance improvement and process improvement skills and knowledge of methodologies such as Lean, Six Sigma, DMAIC, and PDCA Highly proficient in Microsoft Project and the Microsoft Office Suite (Word, Excel, PowerPoint, Visio) Comprehensive digital marketing skills Preferred Skills & Experience: Experience managing healthcare-related projects and familiarity with healthcare provider industry Seven years experience in performance/process improvement projects preferred. Education: Required Education: Bachelors degree in Industrial Engineering, Business/Healthcare Administration, Life Sciences or equivalent Medical Foundation, Physician Practice or Health Plan related experience Preferred Education: Masters degree in Industrial Engineering, Business/Healthcare Administration, or Public Health Consulting experience OR Masters degree in Healthcare Administration or Public Health. This is the pay range that RightSourcing (a part of Magnit) reasonably expects to pay someone for this position, however, as a supplier your expected pay range may vary and/or include certain benefits like: Stipends (for clinical traveler workers only), Medical, Dental, Vision, 401K [include any compulsory benefits such as commissions, incentive bonuses, etc. if applicable]. Required Education: Bachelors degree in Industrial Engineering, Business/Healthcare Administration, Life Sciences or equivalent Medical Foundation, Physician Practice or Health Plan related experience Schedule Notes: 2 Openings for Quality Management Team - Roles are very specific - candidates must have in-depth experience in Clinical Quality Improvement in a hospital inpatient setting. Contract to Hire opportunities for the right talent. 100% Onsite *Candidates must possess all 4 of the below or they will not be considered: 1. Completed PI training and certification (six sigma, lean, CPHQ, Masters in Improvement) from nationally recognized organizations (e.g., ASQ). 2. Current or past formal position in Quality Improvement/Performance improvement (minimum 2 years) 3. History of leading and improving quality outcome metrics such as readmissions, mortality, hospital acquired conditions (infections, falls, pressure injuries, medication errors), sepsis care, venous thromboembolism, unplanned extubations, delirium, complications, c-section, exclusive breastfeeding, etc). 4. Experience using key driver diagrams, pareto charts, excel pivot tables, project management tools.
    $87k-132k yearly est. 12d ago
  • Quality Control Manager - Federal

    Garney Construction 4.0company rating

    Quality manager job in Temecula, CA

    GARNEY CONSTRUCTION A Quality Control Manager position in Location is available at Garney Construction. Join our Garney team to manage and support project Quality Management Specialists, ensuring each project is successful. The Quality Control Manager is responsible for the implementation, management, and execution of Quality Management Programs for Federal contracting projects. WHAT YOU WILL BE DOING Develop and implement project Quality Management Systems to ensure compliance with contract quality standards Review project CPM schedule to anticipate and request timely submittals Review project schedules and prepare Government meeting notices to support schedules Conduct weekly Quality Control meetings Perform/supervise quality inspections as needed by the project or Project Manager Provide effective and efficient communication with the Federal Government personnel Promote Garney's safety programs and procedures to promote a safe working environment WHAT WE ARE LOOKING FOR 10 years of construction experience, 3 years being Construction Quality Manager experience Bachelor's Degree in Engineering, Construction Management, or related field Current USACOE Construction Quality Management for Contractors Certification EM 385 40 hour and OSHA 30-hour certifications LET'S TALK THE PERKS! Salary Range - $136,200-$154,300 Employee Stock Ownership Plan (ESOP) 401K Retirement plan Health, dental, vision and life insurance Flexible Spending Account (FSA) / Health Savings Account (HSA) Long-term disability Wellness program Employee Assistance Plan Holidays and PTO Bonus program CONTACT US If you have questions about the position, please contact Patrick Duque at ************************ . Please include resumes, references, job lists, and any other relevant documentation. Garney Construction and its subsidiaries are committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity/Affirmative Action Employer and it is our policy to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Garney Construction is a background screening, drug-free workplace. Agency Disclaimer: All vendors must have a signed Garney Construction Agreement, authorized by the Executive Team, to receive payment for any placement. Verbal or written commitments made by anyone other than a member of the Executive Team will not be considered binding. Any unsolicited resumes sent to Garney Construction or submitted to employees outside of the Recruiting Team will be deemed the property of Garney Construction. In such cases, Garney Construction will not be obligated to pay any placement fees.
    $136.2k-154.3k yearly Easy Apply 60d+ ago
  • Quality Control Manager

    Techflow Inc. 4.2company rating

    Quality manager job in Oceanside, CA

    Quality Control Manager- Camp Pendleton Competitive Salary and EMPLOYER PAID INSURANCE! EMI Services is hiring a Quality Control Manager (QCM) to work directly with the project manager, the operations manager, the safety supervisor, as well as the United States Government. This position assures quality services to customers: reports performance levels and degrees of compliance with an established QC program. The QCM is required to test and inspect services and work performed for compliance with contract requirements and performance standards. Evaluate data and write reports to validate or indicate deviations. Recommend modifications or necessary actions to achieve optimum quality. Monitor building conditions for possible QC issues or violations, in conjunction with the Safety Supervisor. Also, monitor work assignments and projects for safety or health issues. In addition, the QCM produces and analyzes reports and makes recommendations for quality improvements, as well as, investigates complaints and report's findings to the project manager. The ideal EMI Quality Control Manager promotes quality and customer services excellence. Salary Starting at $100,000 (DOE) plus employer paid insurance! Key Responsibilities * Work closely with Project Manager, FSM, SSHO, subcontractors and QCI Staff * ALL aspects Quality Control Inspection and documentation of Service and Maintenance work * Develop and maintain quality surveillance and tracking system for maintenance shops and subcontractors * Develop and implement QC plan, ensuring environmental plan compliance, performance monitoring, analysis and reporting * Advise the Project Manager on quality control and environmental program status, strategies, issues and potential problem areas * Monitor and track specialized qualifications or credentials such as licenses, certificates, degrees or training needed by personnel * Enforce all regulatory, base and company specific safety rules * Manage Quality Control Inspectors * Lead monthly QCM with Government * Execute additional duties and responsibilities as assigned and/or required to complete the project Essential Skills * Effective oral and written communication skills * Strong organizational, interpersonal skills * Type; operate a personal computer, with emphasis on accuracy, mental alertness, and neatness * Demonstrated ability to work accurately, follow procedures and schedules, and prioritize multiple tasks * Ability to read and understand blueprints, specifications, and contract requirements * Proficiency with all MS Office products (Word, Excel, Access, PowerPoint) * Ability to work successfully in a team environment, aligning with company culture and processes * Must possess a strong work ethic and values that are above-reproach * Understand and adhere to policies and procedures as set by EMI Services * Promote and maintain a positive image of EMI Services * Maintain confidentiality of information related to EMI Services, our customers, vendors and employees * Be adaptable and flexible in work situations. Establish priorities to ensure completion of tasks in a timely manner * Inform the Project Manager of all pertinent problems, irregularities, and other important information within area of responsibility * Adhere to safety policies and procedures to include proper use of personal protective equipment
    $100k yearly 4d ago
  • Program Manager Quality Improvement

    Huckeye Health Services LLC

    Quality manager job in Newport Beach, CA

    Job Description Job Title: Program Manager Quality Improvement Job Type: Contract to Hire Department: Quality Management Schedule: Full Time Hourly Rate: $90- $100/hr depending on experience Required Experience: - Candidates must have in-depth experience in Clinical Quality Improvement in a hospital inpatient setting. *Candidates must possess all 4 of the below or they will not be considered: 1. Completed PI training and certification (six sigma, lean, CPHQ, Masters in Improvement) from nationally recognized organizations (e.g., ASQ). 2. Current or past formal position in Quality Improvement/Performance improvement (minimum 2 years) 3. History of leading and improving quality outcome metrics such as readmissions, mortality, hospital acquired conditions (infections, falls, pressure injuries, medication errors), sepsis care, venous thromboembolism, unplanned extubations, delirium, complications, c-section, exclusive breastfeeding, etc). 4. Experience using key driver diagrams, pareto charts, excel pivot tables, project management tools. Required Education: - Bachelor's degree in Industrial Engineering, Business/Healthcare Administration, Life Sciences or equivalent Medical Foundation, Physician Practice or Health Plan related experience Preferred Skills & Experience: -Master's degree in Industrial Engineering, Business/Healthcare Administration, or Public Health -Consulting experience Please apply online and email resume to: *************************************
    $90-100 hourly Easy Apply 18d ago
  • Quality Control Manager

    Safety Management 3.7company rating

    Quality manager job in San Diego, CA

    Full-time Description As a Construction Quality Control Manager (QCM), your construction expertise and excellent organizational skills will be crucial in ensuring our projects meet or surpass the Client's expectations. Working closely with the on-site team, you will actively schedule, plan, and manage technical activities to ensure accuracy and quality throughout the entire project. Your keen attention to detail will guarantee that all project documents, from start to finish, are accurate and complete. Company Culture At Smart Safety Group, we trust your skills and expertise. As a Construction Project Manager, you have the freedom to make decisions, explore new ideas, and grow professionally while adhering to our commitment to excellence. Teamwork is essential to us. You'll be part of a collaborative and supportive environment where we value the power of working together to achieve great results. We support your professional development at Smart Safety Group. We provide incentives to help you achieve your goals. If you're looking for opportunities to grow, Smart Safety Group offers room for advancement. Many of our key leaders started their careers in the field, showing that there are possibilities for you to progress within our organization. Key Responsibilities Create and execute a project-specific Quality Control Plan. Manage and maintain the QC software. Coordinate testing services and additional inspections as required by the contract. Understand and apply contract specifications accurately. Conduct weekly QC meetings. Complete all QC system documents such as daily reports and record drawing maintenance. Identify, document, track, and oversee the completion of re-work items. Communicate with the Client, subcontractors, and suppliers using various methods like meetings, emails, letters, and phone calls. Keep track of, prepare, review, and submit necessary documents on time to ensure accuracy. Conduct inspections before and after completing different parts of the work. Prepare and submit reports promptly. Carry out LEED coordinator duties, if applicable. Attend project meetings. Focus on site safety practices. What We Offer Health, dental, and vision insurance premiums 100% paid. Wages: $35 - $45 per hour Health Insurance Dental Insurance Vision Insurance Life Insurance 401(k) with 100% match up to 6% of salary Paid time off Professional development assistance Schedule This position may rotate between project work groups that operate under different California-approved schedules. Some work groups follow an Alternative Workweek Schedule of four 10-hour days (4/10), while others operate on a five 8-hour day schedule. Placement into a work group determines the schedule. If a change in work group results in a schedule change, the company will provide notice consistent with California labor regulations and company policy. Full time Hours vary, weekend work may be required. On-site where the project is located. Must be willing to travel. Requirements Qualifications & Experience At least 5 years' construction experience Experience in both civil and building construction. Strong communication skills (both written and verbal) Ability to pass a background check to gain access to work on military bases. Current QC certification with Army Corps of Engineers or Navy (Construction Quality Management for Contractors - CQMC) strongly preferred. B.S. degree in construction management, engineering, or related field preferred Experience with federal or public works construction projects is preferred. Technical Skills Proficient in Excel, Word, Outlook, Teams, etc. Experience with Primavera P6, RMS, Oracle, etc. is preferred. Salary Description $35-$45/hr.
    $35-45 hourly 21d ago
  • FUELS - Quality Control Manager - 90% of Travel

    Bristol Alliance of Companies 4.5company rating

    Quality manager job in San Diego, CA

    The Quality Control Manager-Fuels position is responsible for planning, designing, implementing, and managing quality control and quality assurance processes, procedures, documentation associated with deliverable preparation tracking, and reviews for construction, fuels, environmental remediation, and demolition. Bristol Alliance of Companies (Bristol) is committed to building lasting relationships that reflect our hard work, ingenuity, and dedication to safety. Every employee has an impact on our success, which benefits the Native Culture, land, and people of the Bristol Bay region. Our values: People, Communities, Reputation, Teamwork, Trust, and Truth. Essential Functions Prepare cost estimates and proposals, allocate resources for projects, and oversee field activities. Coordinate with clients, regulatory agencies, and project stakeholders to ensure conformance with contract terms. Represent Bristol Alliance of Companies as Point of Contact for contract, developing and maintaining positive client relationships. Study contract documents to determine appropriate methods for completion and explain plans and contract terms to administrative and field staff. Administer contract pre-planning meeting. Prepare staff loading schedule. Confirm that all required permits and licenses have been obtained. Ensure stakeholders understand their role and specific job duties. Ensure project needs and objectives are being met. Coordinate with designated Quality Control and Health & Safety representatives to ensure Bristol and project standards are met. Minimize company exposure and project performance risks. Manage project changes and prepare change orders where necessary. Prepare or review project submittals, information reports and other project reporting documents as required. Track costs and prepare Accruals and Estimate to Complete reports on a timely basis. Prepare invoices to clients on a timely basis. Prepare field reports and after-action reports. Other duties as assigned. Competencies Ability to track records of meeting production, quality, and customer services standards in a fast-paced construction environment. Skilled in written and oral communication. Knowledge of management for contractors, and appropriate experience and expertise in implementing inspection and testing programs for remediation and construction projects. Ability to be a detail-oriented problem solver. Ability to gather and analyze data, reason logically and creatively, draw conclusions and make appropriate recommendations. Ability to handle multiple projects and tasks, prioritize and organize, and work well under stress in a fast-paced environment. Ability to be flexible and adapt to constant change. Ability to work flexible hours as required to meet deadlines. Skilled in interpersonal communication with staff and clients. Skilled with Microsoft Excel and Word. Knowledge of mentoring field quality technicians. Skilled with USACE-RMS (resident management system). Ability to clearly speak, write, read, and understand English language. Required Education and Experience High school diploma or GED. Bachelor's degree in project management, engineering, or business. Year for year experience may be substituted in lieu of degree. A minimum of 5 years of recent experience as a Project Manager for Construction, Environmental Remediation or Engineering projects. A valid driver's license. Preferred Education and Experience Bachelor's degree in construction management is preferred. Minimum of 2 years' recent experience on commercial/industrial construction projects. Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Position may be subject to both inside and outside environmental conditions, noise sufficient to cause the worker to shout. Position may be subject to a variety of physical conditions - proximity to moving mechanical parts, moving vehicles, electric current, working on scaffolding and high places, exposure to high heat or exposure to chemicals. Position may be subject to atmospheric conditions - fumes, odors, dusts, mist, gases, or poor ventilation. Position may be subject to close visual acuity to perform activities such as viewing a computer terminal and extensive reading. Physical Qualifications 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. Mobility: must be able to stoop, kneel, reach, walk, lift, grasp, feel, talk, hear, and perform repetitive motions. Hearing: must be able to hear audible safety alarms. Visual Acuity: must be adequate to perform the above listed tasks in a safe manner and perform activities such as viewing a computer terminal and extensive reading. Lifting: must be able to exert up to 50 pounds of force occasionally and up to 20 pounds of force frequently, and/or a negligible amount of force constantly to lift, carry, push, pull or otherwise move objects, including the human body. Benefits Excellent salary and benefits package to include paid time off, paid holidays, comprehensive health plan including medical, dental, vision, life, short-term disability insurance, and 401(k) plan with employer match. Equal Opportunity Employer Statement Bristol companies are equal opportunity employers and offer any available positions to all, without regard to race, color, religion, sex, national origin, age, disability, veteran status, parenthood, pregnancy, marital status, or changes in marital status, in accordance with applicable state and federal laws. This applies to recruitment, placement, pay, benefits, training, employment status changes, social and recreational programs, and other conditions and benefits of employment. Bristol grants employment preference first to BBNC and Choggiung shareholders, their spouses, or descendants, and second to Alaska Native Corporation shareholders in accordance with P.L. 93-638. Disclaimer This is not intended to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee. Other duties, responsibilities, and activities may change or be assigned at any time with or without notice. This job description is not a contract or employment. It does not promise or guarantee any particular benefit or specific action. All employment with Bristol is “at-will” which means that Bristol or employee can terminate the employment relationship at any time with or without cause.
    $63k-91k yearly est. 14d ago
  • Quality Patient Safety Program Manager Licensed

    Common Spirit

    Quality manager job in San Bernardino, CA

    Job Summary and Responsibilities * Directors programs involving risk mitigation/management and initiatives related to providing safer care to patients. This position is responsible for providing information to various key stakeholders on the progress and status of described programs/initiatives. * Oversees the implementation of compliance policies and procedures to ensure that they meet organization's compliance requirements. Has management responsibility and accountability for the hospitals' overall compliance with regulations from The Joint Commission, Department of Health Services, CMS and other regulatory agencies. * Oversees the events reporting process, root cause analysis, and event investigation/review. Participates in system office initiatives and programs to mitigate risks identified at other hospitals, resulting in reduced costs and adverse patient outcomes. * Receives and oversees responses to patient complaints and investigates to solve issues promptly. Acts as an intermediary between patients, staff and family to provide clear communication between all parties regarding any outstanding issues Job Requirements To be considered for this role, you'll need to meet the following requirements: Education & Experience * Clinical Experience: You must have at least three (3) years of clinical experience in an acute care setting. * Quality Improvement Experience: You'll also need a minimum of one (1) year of experience in healthcare-related quality management or performance improvement. This could include activities like chart audits, being part of a quality improvement team, or similar roles. Licenses & Certifications You must hold ONE of the following active California licenses upon hire: * Registered Nurse (RN:CA) * Registered Nurse Practitioner (RNP:CA) * Dietitian (DIETITIAN:CA) * Pharmacist (PHARM:CA) * Physical Therapist (PT:CA) * Occupational Therapist (OT:CA) * Speech Language Pathologist (SLP:CA) * Medical Radiographer (MRAD:CA) * Respiratory Care Practitioner (RESP-LIC:CA) * Social Worker (SWORKER:CA) * Doctor of Medicine (MD:CA) * Doctor of Osteopathic Medicine (DO:CA) AND You must obtain ONE of the following certifications within 24 months of your start date: * Certified Professional in Healthcare Quality (CPHQ) * Healthcare Quality Management (HCQM) * Certified Professional in Patient Safety (CPQPS) Where You'll Work Founded in 1910, Dignity Health - Community Hospital of San Bernardino is a 347-bed, acute care, nonprofit, community hospital located in San Bernardino, California. Known for its programs in maternity care and pediatrics, behavioral health and long-term subacute care for adults and children, the hospital also includes inpatient and outpatient surgery. The hospital shares a legacy of humankindness with Dignity Health, one of the nation's five largest health care systems. Visit here ************************************************************ for more information. One Community. One Mission. One California
    $116k-170k yearly est. 7d ago
  • Manufacturing Quality Manager

    Professional. Career Match Solutions

    Quality manager job in Irvine, CA

    Not remote Must be a USA Citizen Salary $79K to $118K plus bonus and benefits Six Sigma Certification QA Manager has managerial oversight of the Irvine site Quality Assurance organization and the Quality Assurance Department within it. The Quality Assurance responsibilities for a manufacturing plant in the aerospace and defense industry include developing, implementing, maintaining a robust quality system and measuring its effectiveness to assure that the products and processes meet internal quality standards and requirements established by customers and regulatory agencies. Our four pillars are Customer Centricity, Operational Excellence, Innovation, and People. Responsibilities: Manage a highly focused site quality organization, aligned with overall global quality expectations. Directly Manage Quality Engineers, Inspection Supervisor and inspectors. Coordinating their activities and schedules to support the Site Production and Customer needs. Ensures the products & services provided to customers meet customer requirements and regulatory standards at both the production & product evaluation level. Ensures the compliance to Quality objectives (quality costs, product defects, customers satisfaction, etc) the effectiveness of corrective measures, and compliance to AS9100 as well as MIL-STD- 790. Coordinates the fulfillment of the Inspection Procedures (Raw Material and/or Processes & Final Product) to ensure the Quality Requirements are achieved and maintained. Develops and analyzes Process Performance through metrics of First Pass Yield, First Piece Inspection as well as using APQP methods. Supports the management of business quality systems and applicable certification systems (ISO, MIL, AS, etc) including the development, maintenance & updating of documentation, processes, and records. Represent the company before regulatory agencies (DLA, NavAir), Customers, and/or Certification Registrars. Manages and participates in failure analysis, complaints, resolution & information request from customers. Supports Continuous Improvement Programs, Lean Manufacturing, Six Sigma, etc. Manage customer escapes, Notices of escapement and develop reports to track progress of investigations as well as corrective measures, while ensuring accuracy and timeliness of reporting to internal and external customers. Manage day-to-day activities of the applicable organization including: goal setting, QE activity, Inspection activity and timeliness of those activities. Develop, groom, train and manage talent by providing coaching and mentoring to build strong performing teams Works effectively in a highly cross-functional environment, balancing multiple goals and priorities. US Citizen BS degree in a technical field Strong managerial, communication and reporting skills Overall technical experience in manufacturing processes and materials used in the connector industry. 3-5 years of direct experience in a Manufacturing/Quality 5 years of management experience leading highly focused technical organizations Direct experience with APQP practices Small assembly manufacturing Proficient in Microsoft Word, Excel and PowerPoint. Experience in MS Project a plus Lean Six Sigma certification Familiarity with military, industry and aerospace standards such as Mil-STD-790, AS9100, ISO9001 and ISO17025 Experience with DLA or other Qualifying Activities as it relates to Mil qualified products Span of Control: 8 - 12 engineers and technicians
    $79k-118k yearly 60d+ ago
  • Senior Quality Control Manager

    Clark Construction Group, LLC 4.7company rating

    Quality manager job in San Diego, CA

    As a Senior Quality Control Manager, you will ensure the project is built within contract document specifications, owner requirements, and comply with local, state, and federal building codes. You will coordinate with other trades, process daily reports of project progress and adhere to all guidelines issued by the owner. As a strong communicator, you will help to build a quality control team that is open, transparent, and delivers excellence. **Responsibilities** + Partner with the project team to understand, plan, and implement the contract drawings and specifications + Collaborate with the owner, design team, and contractors to ensure quality and timeliness of project construction and completion + Implement and manage the "Three Phases of Control" Quality Control Plan + Oversee submittal review and approval + Schedule and conduct quality control meetings - Preparatory, Initial Phase, Follow-up + Control documents related to quality control functions + Establish testing procedures in accordance with contract specifications + Manage inspections process + Coordinate third party testing agents and interface with the Owner's representatives as required + Closely track and maintain a project deficiency log + Manage the punch list process + Oversee project closeout deliverable process-training, O&Ms + Confer directly with the executive management team + Encourage, lead, and/or participate in staff training and development + Proactively identify and develop relationships with industry professionals to generate and win the right work + Take an active role in recruiting top industry talent to join the Clark team. Identify, hire, and retain outstanding people + Exceed our stakeholders' expectations by anticipating their needs, desires, and goals **Basic Qualifications** + Undergraduate degree in a construction or related discipline or relevant experience + Minimum 8-10+ years verifiable construction quality control and/or inspection experience + Experience within building / commercial construction + Takes initiative and personal responsibility to always deliver value and excellence + Uses expertise to create a vision and aligns the team to deliver/achieve desired outcomes + A track record of establishing/contributing to creative strategic solutions + Ability to communicate effectively with, persuade, and gain "buy-in" from, a broad range of stakeholders (e.g., executive team, leadership team, Business Unit Leaders, direct reports, clients, trade partners, and third party providers + Alignment to Clark Standards of Excellence: self-motivated, results oriented, adaptable, team player, accountable, ethical, innovative, resilient, builds relationships, builds people/teams and followership, sets direction and executes **Preferred Qualifications** + Experience in large scale construction management or construction trade with increasing levels of responsibility + Must be able to manage other inspectors and submittal clerks, as well as coordinate independent material testing and lab work + Ability to process a large volume of submittals / RFIs + Prior experience developing and managing Quality Control Plans The work environment and requirements described below are representative of those necessary for an employee to successfully perform the essential functions of this role. **The Physical Side of the Role:** This is an active, hands-on role. You can expect to be on your feet frequently, navigating active job sites with uneven terrain, stairs, ladders, and hoists. The work is physically demanding and requires a full range of motion, including bending, kneeling, and reaching. You'll need to be comfortable frequently lifting and carrying materials up to 25 pounds, and occasionally up to 50 pounds. This role requires the ability to communicate effectively, as well as visual acuity for reading plans and inspecting work. The role does include desk time in the office that may require prolonged periods of sitting for tasks like computer work, document review, and meetings. **Your Work Environment:** You'll spend a significant amount of your time on active construction sites, which means being adaptable to all kinds of weather and moderate to loud noise levels, and comfortable in elevated or confined work areas with moving mechanical equipment and with the fast-paced nature of a project in progress. You will also spend time in a typical office setting with moderate noise levels. Your safety is our top priority, and you'll be expected to follow Clark Construction's safety policies and procedures, and all applicable laws, at all locations. **Our High-Performing Culture:** This is a demanding, high-performance environment. We are looking for candidates who are energized by challenge, thrive under pressure, and are prepared to do what it takes to achieve exceptional results. Success in this role requires significant commitment, including flexibility to work extended hours, especially during critical project phases or client deadlines. Beyond regular working hours, there will be occasions where business needs require your attention, particularly for time-sensitive matters or emergencies. You are expected to monitor and respond to communications (phone calls, emails, text messages) as required to address these situations effectively. Your ability to manage these expectations and be responsive when critical issues arise is key to your success in this role and our collective success as a team. **A Drug Free Workplace:** Clark promotes a drug free workplace. A pre-employment drug "fitness for duty" screening is required, and the company conducts random quarterly drug "fitness for duty" tests. _Clark offers a total compensation package that includes base salary, bonus potential, and a comprehensive benefits package including health/dental/vision benefits, paid time off, retirement/401k, and Company Contribution plan. Additional benefits include life insurance, commuter benefit, short & long term disability, fitness reimbursement, FSA, tuition reimbursement, back-up daycare, tutoring & family support benefits, EAP/Work-Life assistance, and a holiday contribution program. For this role the base salary range i_ _s_ _$110,000-220,000._ _Compensation may vary_ _outside of this range_ _depending on a number of factors, including a candidate's education, experience, skills, and geographic location. Base pay is one part of the Total Compensation Package that is provided to compensate and recognize employees for their work._ _*********************************************************** \#LI-KS1 Clark Construction Group is one of the largest building and infrastructure companies in the United States. Our portfolio spans every major building market, from public to private, corporate to cultural, education to entertainment, and the infrastructure connecting it all - power, transportation, water, and roadways. Since 1906, we've been delighting and delivering value to our clients and project partners, providing diverse opportunities for our team, and strengthening the communities where we live. With offices strategically located across the country, we pride ourselves on being a local builder with national reach. Learn more about Clark Construction (*********************************** . There is a sense of camaraderie that comes with delivering impactful projects as a team. It creates a sense of humility and fosters pride in the work we do. At Clark, we are proud to build what matters, together. Learn more about careers at Clark (****************************************** . Find even more opportunities with the Clark Group, our collection of companies - delivering construction and asset solutions for clients across the United States. Clark Group's capabilities span the entire asset lifecycle - from project development and financing to construction and facility maintenance. **_Asset Solutions_** **Altura Associates (********************************************* **Coda** **Edgemoor Infrastructure & Real Estate (************************************************ **S2N Technology Group** _Building & Infrastructure_ **Atkinson Construction (*********************************************** **Shirley Contracting Company** **C3M Power Systems (************************************************** **_Equal Opportunity Employer_** Clark Construction Group, LLC (and its subsidiaries and affiliates) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, age, national origin, religion, physical and mental disability, genetic information, marital status, sexual orientation, gender identity, citizenship, pregnancy or maternity, protected veteran status, or any other status prohibited by applicable national, federal, state or local law. Clark promotes a drug-free workplace. Applicants have rights under Federal Employment Laws: Family and Medical Leave Act (FMLA), Equal Employment Opportunity (EEO), and Employee Polygraph Protection Act (EPPA). Clark is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please email ************************************ or call ************** and let us know the nature of your request and your contact information. **_Authorization to Work_** Applicants must be currently authorized to work in the US on a full-time basis in order to be considered. Equal Opportunity Employer: Clark Construction Group, LLC, (subsidiaries and affiliates) is an Equal Opportunity Employer committed to diversity and inclusion in the workplace. All qualified applicants will receive consideration for employment without regard to sex, race, color, age, national origin, religion, physical and mental disability, genetic information, marital status, sexual orientation, gender identity/assignment, citizenship, pregnancy or maternity, protected veteran status, or any other status prohibited by applicable national, federal, state or local law. Clark Construction promotes a drug-free workplace.
    $110k-220k yearly 60d+ ago
  • Director of Quality Assurance & Compliance

    Cirsium Biosciences

    Quality manager job in San Diego, CA

    A biotechnology firm located in San Diego, California, is seeking a Director of Quality Assurance to lead the QA function. The role involves developing and implementing GxP quality systems, ensuring compliance with regulatory requirements, and driving continuous improvement. Candidates should have at least 7 years of experience in Quality Assurance within the pharmaceutical or biotech sectors and possess extensive knowledge of GxP regulations. This position offers competitive compensation and employee benefits in a collaborative environment. #J-18808-Ljbffr
    $131k-214k yearly est. 3d ago
  • Director, Quality Engineering

    BD Mexico

    Quality manager job in San Diego, CA

    We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Job Summary The Director, Quality Engineering will lead and strategically direct the quality engineering function, ensuring the design, development, and manufacturing of medical devices meet the highest standards of safety, efficacy, and regulatory compliance. This role is crucial in driving a culture of quality throughout the product lifecycle. Job Responsibilities Strategic Leadership Develop and implement a comprehensive quality engineering strategy aligned with business objectives and regulatory requirements (e.g., FDA, ISO 13485). Team Management Lead, mentor, and develop a team of quality engineers, fostering a high-performance culture and ensuring effective resource allocation. Design Quality Assurance Oversee the application of quality engineering principles in product design and development, including design controls, risk management, and design validation activities. Process Quality Improvement Drive continuous improvement initiatives for manufacturing processes, identifying and addressing quality issues through root cause analysis, corrective and preventive actions (CAPA), and statistical process control. Supplier Quality Management Collaborate with procurement and R&D to establish and maintain a robust supplier quality program, including supplier selection, auditing, and performance monitoring. Regulatory Compliance Ensure all quality engineering activities adhere to applicable regulations and standards, preparing for and supporting internal and external audits. Product Lifecycle Support Provide quality engineering support throughout the entire product lifecycle, from concept to post-market surveillance. Cross-Functional Collaboration Partner effectively with R&D, Manufacturing, Regulatory Affairs, and other departments to integrate quality into all aspects of product development and operations. Metrics & Reporting Establish and monitor key quality metrics, providing regular reports to senior leadership on quality performance and trends. Job Qualifications Education Bachelor's degree in Engineering (e.g., Biomedical, Mechanical, Electrical, Industrial) or a related scientific discipline required. Master's degree preferred. Experience Minimum of 10 years of progressive experience in Quality Engineering within the medical device industry, with at least 5 years in a leadership or management role. Regulatory Knowledge In-depth knowledge of medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, and relevant international regulations. Quality Tools & Methodologies Proficiency in quality tools and methodologies such as FMEA, SPC, MSA, Root Cause Analysis, CAPA, and statistical techniques. Leadership Skills Proven ability to lead, motivate, and develop high-performing teams. Excellent interpersonal and communication skills (written and verbal). Problem-Solving Strong analytical and problem-solving skills with a data-driven approach to decision-making. Certifications (Preferred) ASQ certifications such as Certified Quality Engineer (CQE), Certified Quality Manager (CQM/OE), or Six Sigma Black Belt. Technical Acumen Strong understanding of medical device design, manufacturing processes, and associated quality challenges. At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit********************** Primary Work Location USA CA - San Diego TC Bldg C&D At BD, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You (********************************************** Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly pay offered to a successful candidate is based on experience, experience … … ... ... ... …? ... ... ... ? ? ... ... ... ? ? … Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. #J-18808-Ljbffr
    $145k-224k yearly est. 3d ago
  • Program Manager Quality Improvement

    Apidel Technologies 4.1company rating

    Quality manager job in Newport Beach, CA

    Job Description Responsible for establishing and continuing eective quality improvement eorts to achieve organizational performance goals and national top decile performance in clinical excellence. Quality improvements may be small or large scale and are in alignment with Hoags strategic goals for example, addressing 30-day readmissions and mortality reduction. The Quality Improvement Manager may apply Lean, Six Sigma, and other quality improvement methodologies to deliver results. Job Responsibilities: Coaches and trains teams in the utilization of improvement tools and implementation of improvements. Manages plans and develops guidelines, process measures, targets, and standards for monitoring and measuring results to deliver on goals. Interacts daily with leaders, to identify, dene, and manage opportunities to improve quality while helping create a strategic approach to produce and establish extraordinary improvement. The Program Manager Quality Improvement collaborates to lead and organize eorts for continuous clinical improvement. Skills: Required Skills & Experience: Advanced training or experience in performing statistical, financial and strategic analysis Five years experience in performance/process improvement projects including but not limited to Lean, Six Sigma methodologies Demonstrated performance improvement and process improvement skills and knowledge of methodologies such as Lean, Six Sigma, DMAIC, and PDCA Highly proficient in Microsoft Project and the Microsoft Office Suite (Word, Excel, PowerPoint, Visio) Comprehensive digital marketing skills Preferred Skills & Experience: Experience managing healthcare-related projects and familiarity with healthcare provider industry Seven years experience in performance/process improvement projects preferred. Education: Required Education: Bachelors degree in Industrial Engineering, Business/Healthcare Administration, Life Sciences or equivalent Medical Foundation, Physician Practice or Health Plan related experience Preferred Education: Masters degree in Industrial Engineering, Business/Healthcare Administration, or Public Health Consulting experience OR Masters degree in Healthcare Administration or Public Health. Required Certifications & Licensure: N/A Preferred Certifications & Licensure: Certifications in Lean and/or Six Sigma Methodology Project Management Professional (PMP) certification This is the pay range that RightSourcing (a part of Magnit) reasonably expects to pay someone for this position, however, as a supplier your expected pay range may vary and/or include certain benefits like: Stipends (for clinical traveler workers only), Medical, Dental, Vision, 401K [include any compulsory benefits such as commissions, incentive bonuses, etc. if applicable]. Schedule Notes: 2 Openings for Quality Management Team - Roles are very specific - candidates must have in-depth experience in Clinical Quality Improvement in a hospital inpatient setting. Contract to Hire opportunities for the right talent. 100% Onsite *Candidates must possess all 4 of the below or they will not be considered: 1. Completed PI training and certification (six sigma, lean, CPHQ, Masters in Improvement) from nationally recognized organizations (e.g., ASQ). 2. Current or past formal position in Quality Improvement/Performance improvement (minimum 2 years) 3. History of leading and improving quality outcome metrics such as readmissions, mortality, hospital acquired conditions (infections, falls, pressure injuries, medication errors), sepsis care, venous thromboembolism, unplanned extubations, delirium, complications, c-section, exclusive breastfeeding, etc). 4. Experience using key driver diagrams, pareto charts, excel pivot tables, project management tools
    $87k-132k yearly est. 19d ago

Learn more about quality manager jobs

How much does a quality manager earn in Temecula, CA?

The average quality manager in Temecula, CA earns between $66,000 and $163,000 annually. This compares to the national average quality manager range of $64,000 to $128,000.

Average quality manager salary in Temecula, CA

$104,000
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