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Quality Manager jobs at Medline

- 20 jobs
  • Sr. Manager Regulatory Compliance, Supplier Quality

    Medline 4.3company rating

    Quality manager job at Medline

    Responsible for leading the quality and compliance for the Supplier Quality Program (Audits and Supplier Quality). Set organizational priorities, oversee resource utilization and develop operational plans and policies. Job Description Responsibilities: Monitor and maintain compliance with applicable (ex. QSR, GMP, ISO) pertaining to the applicable life cycle and regions of distribution for the product. Direct and manage complex, high-risk supplier audits and internal audits to evaluate Quality Management Systems (QMS) and regulatory compliance for manufacturers, contract sterilizers, laboratories, and raw material suppliers. Act as a senior liaison with Divisions, Suppliers, Manufacturing, and Operations leadership to ensure quality products, timely delivery, and customer satisfaction. Leads the process and team during investigations and identifying resolutions for issues relating to the audit program by interfacing with Divisions, Suppliers, Manufacturing, and/or Operations. Devise and implement continuous improvement initiatives, develop best practices, and participate in policy-setting activities to enhance supplier quality globally. Oversee the execution the audit plan and own all audit escalations. Creates and oversees the supplier quality program and ensures all suppliers are held to appropriate rigor based on their risk Provides Leadership support during internal/external regulatory audits. Performs audits with their teammates and individually. Management responsibilities include: Typically, manages through multiple Managers and/or Supervisors Oversee major projects/programs/outcomes; Budget responsibility; Responsible for ensuring the team has adequate training and is state of the art. Interpret and execute policies for departments/projects and develops; Recommend and implement new policies or modifications to existing policies; Provide general guidelines and parameters for staff functioning; Hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies. Qualifications: Typically requires a Bachelor's degree in Engineering, Science, or Technical Field. Work Experience At least 7 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, risk management, including working in compliance with QSR/GMP/ISO requirements or other regulated industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR). At least 3 years of management experience. Preferred Qualifications: At least 5 years of direct experience with recall management Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization. The anticipated salary range for this position: $152,880.00 - $229,320.00 Annual The actual salary will vary based on applicant's location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold. Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. We're dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here. Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
    $152.9k-229.3k yearly Auto-Apply 16d ago
  • Manager, Quality Engineering

    Stryker 4.7company rating

    Irvine, CA jobs

    Work Flexibility: Onsite Join a team where innovation meets impact! Stryker - Inari Medical is hiring a Manager, Quality Engineering in Irvine, California! In this role, you'll lead and mentor a high-performing team of Design Quality Engineers who are shaping the future of medical technology. You'll guide and support their efforts on high-impact new product development (NPD) projects, ensuring design requirements are met and manufacturing processes are optimized to deliver life-changing solutions to patients! This is an onsite position with the option to work remotely one day per week. What You Will Do: Drive talent strategy by attracting, developing, and retaining top engineering talent while fostering a culture of growth and high performance. Lead high-complexity projects from concept to execution, managing budgets, timelines, and staffing to meet business goals. Ensure technical excellence by overseeing design control activities for new and existing products and processes, guiding teams through risk management (e.g., FMEA), and reviewing or delegating approval of regulatory documentation in compliance with FDA 21 CFR Part 820 and ISO 13485. Make independent decisions on projects, programs, and portfolio-level challenges to drive successful outcomes and support business strategy. Mentor and develop team members by translating department goals into clear performance objectives and providing actionable feedback. Influence cross-functional collaboration by building strong relationships across technical teams and business units-including Regulatory Affairs, Quality, Marketing, Clinical, Operations, and Finance-to drive innovation and alignment. Partner with customers and key opinion leaders (KOLs) to develop technical strategies that align with clinical and business needs. Contribute to financial strategy by managing project-level budgets and supporting broader R&D financial planning. What You Will Need Required Qualifications Bachelor's degree in engineering or applicable technical discipline. 8+ years of experience in engineering or a related technical field. Experience in the medical device industry. 3+ years of direct people management experience. Preferred Qualifications Experience across the entire product lifecycle. Experience mentoring in one or more technical or functional disciplines. Proven ability to deliver programs on time, within budget, and to quality standards. General knowledge of the healthcare market and competitive landscape. Experience executing talent and performance management strategies. Demonstrated ability to communicate complex technical plans across teams and leadership levels. $132,900 - $217,500 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors. Travel Percentage: 10%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
    $132.9k-217.5k yearly Auto-Apply 60d+ ago
  • Manager, Quality Engineering

    Stryker 4.7company rating

    Irvine, CA jobs

    **Join a team where innovation meets impact!** Stryker - Inari Medical is hiring a **Manager, Quality Engineering** in **Irvine, California** ! In this role, you'll lead and mentor a high-performing team of Design Quality Engineers who are shaping the future of medical technology. You'll guide and support their efforts on high-impact new product development ( **NPD** ) projects, ensuring design requirements are met and manufacturing processes are optimized to deliver life-changing solutions to patients! This is an onsite position with the option to work remotely one day per week. **What You Will Do:** + **Drive talent strategy** by attracting, developing, and retaining top engineering talent while fostering a culture of growth and high performance. + **Lead high-complexity projects** from concept to execution, managing budgets, timelines, and staffing to meet business goals. + **Ensure technical excellence** by overseeing design control activities for new and existing products and processes, guiding teams through risk management (e.g., FMEA), and reviewing or delegating approval of regulatory documentation in compliance with FDA 21 CFR Part 820 and ISO 13485. + **Make independent decisions** on projects, programs, and portfolio-level challenges to drive successful outcomes and support business strategy. + **Mentor and develop team members** by translating department goals into clear performance objectives and providing actionable feedback. + **Influence cross-functional collaboration** by building strong relationships across technical teams and business units-including Regulatory Affairs, Quality, Marketing, Clinical, Operations, and Finance-to drive innovation and alignment. + **Partner with customers and key opinion leaders (KOLs)** to develop technical strategies that align with clinical and business needs. + **Contribute to financial strategy** by managing project-level budgets and supporting broader R&D financial planning. **What You Will Need** **Required Qualifications** + Bachelor's degree in engineering or applicable technical discipline. + 8+ years of experience in engineering or a related technical field. + Experience in the medical device industry. + 3+ years of direct people management experience. **Preferred Qualifications** + Experience across the entire product lifecycle. + Experience mentoring in one or more technical or functional disciplines. + Proven ability to deliver programs on time, within budget, and to quality standards. + General knowledge of the healthcare market and competitive landscape. + Experience executing talent and performance management strategies. + Demonstrated ability to communicate complex technical plans across teams and leadership levels. $132,900 - $217,500 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors. Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role. Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
    $132.9k-217.5k yearly 60d+ ago
  • Director, Quality Operations Distribution

    McKesson Corporation 4.6company rating

    Columbus, OH jobs

    McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow's health today, we want to hear from you. The Director of Quality Operations, Distribution is responsible for leading all quality-related activities for wholesale distribution, 3PL, national brands, and government operations. This role ensures compliance with regulatory standards, drives continuous improvement, and fosters a culture of quality across the organization. The Director will oversee strategic planning, process improvements, quality control systems, and team leadership while collaborating with supply chain, customer service, category management, and sales teams. Key Responsibilities: Quality Assurance & Regulatory Oversight * Ensure regulatory and operational standards are established, executed, and monitored within distribution centers. * Oversee temperature monitoring and documentation for product storage areas. Investigation Leadership * Lead investigations into complaints and CAPA for product and process quality issues, including diversion and illegitimate products. Audit Preparation & Hosting * Prepare distribution centers for regulatory inspections and host external audits from suppliers and regulatory bodies. Data & Analytics * Develop and monitor KPIs, compile compliance reports, and provide recommendations for improvement. Compliance Training Resource * Act as a training resource for cGxP and ISO compliance; maintain up-to-date SOP training records. Minimum Qualifications: Education: Bachelor's degree or higher in Engineering, Science, or related field. Experience: * 10+ years in leadership roles within scientific fields or Quality Assurance in distribution or commercial manufacturing of medical devices/pharmaceuticals. * Clear understanding of cGxPs. * Experience leading FDA, Board of Pharmacy, and/or NABP inspections. Specialized Knowledge & Skills: * Expertise in regulatory requirements for distribution QA (CFR 205, 820, 210, 211, DSCSA, Hazmat, Cold Chain). * Strong verbal and written communication skills. * Organizational, problem-solving, and decision-making abilities. * Strategic thinking and change management skills. Working Conditions: * Traditional office environment. * Significant computer and phone-based work. Travel Requirements: * Up to 50% travel, including overnight and air travel. Compensation: * Estimated Salary Range: $140,000 - $180,000 annually (depending on experience and location). * Eligible for annual performance bonus and comprehensive benefits package including medical, dental, vision, 401(k), and paid time off. Additional Requirements: * Must be authorized to work in the U.S. * Sponsorship is not available for this position. Equal Opportunity Statement: McKesson is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status. Criminal history will not disqualify qualified applicants. Accommodation Notice: If you need a reasonable accommodation for your job search or application, please contact: Disability_Accommodation@McKesson.com. Resumes or CVs sent to this email will not be accepted. We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, please click here. Our Base Pay Range for this position $128,500 - $214,100 McKesson is an Equal Opportunity Employer McKesson provides equal employment opportunities to applicants and employees and is committed to a diverse and inclusive environment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age or genetic information. For additional information on McKesson's full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page. Join us at McKesson!
    $140k-180k yearly Auto-Apply 33d ago
  • Senior Manager, Clinical Operations Quality Assurance, Pharma and Medical Device (REMOTE)

    Baxter 4.2company rating

    Deerfield, IL jobs

    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 at Baxter: As a skilled Senior Manager, Clinical Quality Assurance, you will lead our clinical quality assurance efforts across Baxter. You will be responsible for proactively anticipating regulatory changes, ensuring compliance with industry best practices, and driving process improvements in clinical trials for all products - pharmaceuticals and medical devices. You'll bring a strong understanding of clinical regulations, quality management systems, and industry trends. What You'll Be Doing: Clinical Quality Assurance Leadership: Independently lead the development and implementation of clinical quality assurance strategies to ensure compliance with regulatory requirements Proactively anticipate the horizon of regulations and ensure that current GCP/Clinical Trial practices reflect current and future industry practice Provide clinical quality leadership, expertise, and support to Clinical Operations and the CMSO Provide subject matter expertise to the MA teams and leadership regarding clinical quality matters with respect to the current regulatory landscape Review and approve GQPs involving Human Subjects Research and Human Clinical Research Quality Assurance Activities: Plan and monitor quality activities for Clinical Trials, including all phases of clinical trials and post-market clinical studies Conduct sponsor clinical sites and vendor assessments as required Lead internal and/or regulatory audits of Clinical Trials and/or Clinical Operations Handle clinical escalations, non-conformances, or CAPAs related to Clinical Trial operations and/or Clinical vendors Manage New Supplier Request process for Clinical vendors Consult and approve risk-based approaches developed by Clinical Leadership for human clinical research sponsored by Baxter Assess impact of Field Actions on ongoing or planned clinical trials Regulatory Compliance: Interpret clinical regulations and provide guidance to Clinical Operations Ensure compliance with regulatory requirements, including GCP, FDA & EMEA regulations, and other relevant standards Serve as an interface for inspections, audits, and inspections relating to GCP compliance Quality Metrics and Risk Management: Assist in collecting quality metrics for adequate study oversight Identify and assess regulatory and quality risks in activities and processes as necessary according to regulatory agency rules and guidelines and Baxter quality practices Process Improvements and Initiatives: Drive process improvements and initiatives in support of continuous process improvements Maintain current and leading-edge expertise in quality management systems and quality techniques Stay up-to-date with related quality legislation and compliance around clinical trials Travel to regulatory agencies, industry conferences, and other external meetings as required (not expected to exceed 25%) Your Team: As the Senior Manager, Clinical Quality Assurance, you will report directly to the Associate Director, Clinical Operations, Operations & Governance, Worldwide Medical & Regulatory and work collaboratively with cross-functional teams to ensure the delivery of high-quality clinical data and reports. Your Location: The role is located at our global corporate headquarters in the greater Chicago, IL area northern suburb of Deerfield. Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change. Alternatively candidates residing anywhere in the US will also be considered. What You'll Bring: • Bachelor's degree in a life science or related field is required • Minimum 5-7 years of experience in clinical quality assurance, regulatory affairs, or a related field • Experience in managing clinical quality assurance teams and developing quality management systems • Experience in Clinical Trials, Phase 0 - IV. • Experience in Pharmaceutical and Medical Device Clinical Trials • Experience performing laboratory, GCP, GMP audits a plus. • Strong knowledge of clinical regulations, quality management systems, and industry trends • Ability to work independently and drive clinical quality assurance strategy and plans • Experience with clinical data management systems and processes • Strong leadership and communication skills • Ability to analyze and interpret complex data • Experience with quality management systems and auditing #LI-JR1 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 our employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $136,000 - $187,000 annually. The estimated range 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 upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses and/or long-term incentive. 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. 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.
    $136k-187k yearly Auto-Apply 58d ago
  • Supervisor, Quality Engineering (Mentor, OH, US, 44060)

    Steris Corporation 4.5company rating

    Mentor, OH jobs

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The Quality Engineering Supervisor leads a team of quality engineers, technicians and inspectors focused on process and product quality improvement for multiple production lines/values streams. This role has responsibility for incoming product/component inspection, NCR investigation, production quality, and final QC inspection/testing. The Quality Engineering Supervisor has responsibility for internal and customer facing key metric performance for assigned production lines/value streams. This role is responsible for the hiring, development, and overall management of his/her Quality team. This individual develops and manages work assignments, analyzes, and trends Quality performance data and utilizes problem solving methods to improve processes and eliminate Quality issues. The Quality Supervisor works closely with CI resources in the site to drive overall Lean and Quality improvements. In addition, as a contributor to Quality System compliance, the Quality Supervisor supports the site to ensure the Quality System adheres to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other regulatory standards, as applicable. Relocation assistance available What You'll do as Supervisor Quality Engineering * Lead assigned Quality team focused on overall manufacturing/servicing quality improvement for key internal and customer facing metrics. * Lead assigned Quality team focused on internal production quality by improving component and process non conformances; production line DPU (defect per unit); production FPY (first pass yield). * Lead assigned Quality team to improve customer facing and internal product/service and process quality key metrics through robust data analysis and improvement/problem solving projects. * Ensure robust production and process controls that are in alignment with production and Lean strategies. * Align production product and service quality improvement to supplier improvement strategies and tactics. * Establish individual and team objectives to attain key metric performance and ensure alignment to the overall Quality strategy. * Lead the Team's talent development processes and knowledge development. * Assume other duties as assigned. The Experience, Skills, and Abilities Needed Required: * Bachelor's Degree (Engineering or related technical field) with minimum 5 years of Quality Engineering experience * Minimum 5 years of experience working within a regulated or certified Quality Management System * Minimum 3 years of experience with supplier quality * Minimum 3 years of experience in Lean methods * Minimum 3 years supervising/leading employees Preferred: * Minimum 5 years of experience in healthcare, medical device, or other regulated industry * ASQ, QSR, or familiarity with QSR/GMP regulations Other: * Customer Focused: Demonstrates a "Customer first" mindset, responds with a sense of urgency * Teamwork: Collaborates with others, works in a professional manner to support team actions * Results: Effectively manages work tasks, is detail oriented and strives for continuous improvement, ability to analyze technical issues, ability to cope with change and shifting priorities * Communication: Constructs clear written communication. Keeps manager and co-workers informed * Job Knowledge: PC experience and working familiarity of common desktop applications including Excel, Visio, Minitab, and Word * Initiative/Leadership: Takes ownership of task and projects and seeks clarification if unsure of direction * Ability to analyze and interpret data; utilize problem solving methodologies and drive process improvements What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future. Here is a brief overview of what we offer: * Market competitive pay * Extensive paid time off and (9) added holidays * Excellent healthcare, dental, and vision benefits * Long/short term disability coverage * 401(K) with company match * Maternity and parental leave * Additional add on benefits/discounts for programs such as pet insurance * Tuition reimbursement and continued educational programs * Excellent opportunities for advancement in a stable long-term career #LI-HT Pay range for this opportunity is $90,737.50 - $117,425.00. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc. STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits Open until position is filled. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
    $90.7k-117.4k yearly 30d ago
  • Coding Quality Auditor - Remote

    Tenet Healthcare Corporation 4.5company rating

    Frisco, TX jobs

    Conducts data quality audits of inpatient admissions and outpatient encounters to validate coding assignment is in compliance with the official coding guidelines as supported by clinical documentation in health record. Validates abstracted data elements that are integral to appropriate payment methodology. ESSENTIAL DUTIES AND RESPONSIBILITIES Include the following. Others may be assigned. * Consulting: Consults facility leaders and staff on best practices, methodology, and tools for accurately coding. * Chart Analysis IP, OP Coding Data auditing and validation: Reviews medical records for the determination of accurate assignment of all documented diagnoses and procedures. Adheres to Standards of Ethical Coding (AHIMA). Reviews medical records for the determination of accurate assignment of all documented diagnoses and procedures. Reviews claim to validate abstracted data including but limited to discharge disposition which impacts facility reimbursement and/or MS-DRG assignment. Adheres to Standards of Ethical Coding (AHIMA).Reviews medical records to determine accurate required abstracting elements (facility/client/payer specific elements) including appropriate discharge disposition * IP, OP Coding: Reviews medical records for the determination of accurate assignment of all documented ICD-9-CM codes for diagnoses and procedures. Abstracts accurate required data elements (facility/client specific elements) including appropriate discharge disposition. * Coding: Uses discretion and specialized coding training and experience to accurately assign ICD-9, CPT-4 codes to patient medical records. * Abstracting: Reviews medical records to determine accurate required abstracting elements (client specific elements) including appropriate discharge disposition. * Coding Quality: Demonstrates ability to achieve accuracy and consistency in the selection of principal and secondary diagnoses (including MCC & CC) and procedures. Demonstrates ability to achieve accuracy and consistency in abstracting elements defined by SOW. * CDI: Identifies and communicates documentation improvement opportunities and coding issues (lacking documentation, physician queries, etc.) to appropriate personnel for follow-up and resolution. * Professional Development: Stays current with AHA Official Coding and Reporting Guidelines, CMS and other agency directives for ICD-9-CM and CPT coding. Attends mandatory coding seminars on annual basis (IPPS and OPPS, ICD-9-CM and CPT updates) for inpatient and outpatient coding. Quarterly review of AHA Coding Clinic. Attends Quarterly Coding Updates and all coding conference calls KNOWLEDGE, SKILLS, ABILITIES To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * Ability to consistently code at 95% accuracy and quality while maintaining client specified production standards * Must successfully pass coding test * Knowledge of medical terminology, ICD-9-CM and CPT-4 codes * Must be detail oriented and have the ability to work independently * Computer knowledge of MS Office * Must display excellent interpersonal skills * The coder should demonstrate initiative and discipline in time management and assignment completion * The coder must be able to work in a virtual setting under minimal supervision * Intermediate knowledge of disease pathophysiology and drug utilization * Intermediate knowledge of MSDRG classification and reimbursement structures * Intermediate knowledge of APC, OCE, NCCI classification and reimbursement structures Conifer requires its candidates, as applicable and as permitted by law, to obtain and provide confirmation of all required vaccinations and screenings prior to the start of employment. This may include, but is not limited to, the COVID-19 vaccination, influenza vaccination, and/or any future required vaccines and screenings. EDUCATION / EXPERIENCE * Associates degree in relevant field preferred or combination of equivalent of education and experience * Three years coding experience including hospital and consulting background CERTIFICATES, LICENSES, REGISTRATIONS * AHIMA Credentials, and or AAPC PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * Duties may require bending, twisting and lifting of materials up to 25 lbs. * Duties may require driving an automobile to off- site locations. * Duties may require travel via, plane, care, train, bus, and taxi-cab. * Ability to sit for extended periods of time. * Must be able to efficiently use computer keyboard and mouse to perform coding assignments. WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * Floats between clients as requested. * Capacity to work independently in a virtual office setting or at hospital setting if required to travel for assignment. OTHER * Regular travel may be required As a part of the Tenet and Catholic Health Initiatives family, Conifer Health brings 30 years of healthcare industry expertise to clients in more than 135 local regions nationwide. We help our clients strengthen their financial and clinical performance, serve their communities and succeed at the business of healthcare. Conifer Health helps organizations transition from volume to value-based care, enhance the consumer and patient healthcare experience and improve quality, cost and access to healthcare. Are you ready to be part of our solutions? Welcome to the company that gives you the resources and incentives to redefine healthcare services, with a competitive benefits package and leadership to take your career to the next step! Compensation and Benefit Information Compensation * Pay: $30.85 - $46.28 per hour. Compensation depends on location, qualifications, and experience. * Position may be eligible for a signing bonus for qualified new hires, subject to employment status. * Conifer observed holidays receive time and a half. Benefits Conifer offers the following benefits, subject to employment status: * Medical, dental, vision, disability, and life insurance * Paid time off (vacation & sick leave) - min of 12 days per year, accrue at a rate of approximately 1.84 hours per 40 hours worked. * 401k with up to 6% employer match * 10 paid holidays per year * Health savings accounts, healthcare & dependent flexible spending accounts * Employee Assistance program, Employee discount program * Voluntary benefits include pet insurance, legal insurance, accident and critical illness insurance, long term care, elder & childcare, AD&D, auto & home insurance. * For Colorado employees, Conifer offers paid leave in accordance with Colorado's Healthy Families and Workplaces Act. Employment practices will not be influenced or affected by an applicant's or employee's race, color, religion, sex (including pregnancy), national origin, age, disability, genetic information, sexual orientation, gender identity or expression, veteran status or any other legally protected status. Tenet will make reasonable accommodations for qualified individuals with disabilities unless doing so would result in an undue hardship. Tenet participates in the E-Verify program. Follow the link below for additional information. E-Verify: ***************************** The employment practices of Tenet Healthcare and its companies comply with all applicable laws and regulations. **********
    $30.9-46.3 hourly 20d ago
  • Supervisor, Quality Engineering

    Steris 4.5company rating

    Ohio jobs

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The Quality Engineering Supervisor leads a team of quality engineers, technicians and inspectors focused on process and product quality improvement for multiple production lines/values streams. This role has responsibility for incoming product/component inspection, NCR investigation, production quality, and final QC inspection/testing. The Quality Engineering Supervisor has responsibility for internal and customer facing key metric performance for assigned production lines/value streams. This role is responsible for the hiring, development, and overall management of his/her Quality team. This individual develops and manages work assignments, analyzes, and trends Quality performance data and utilizes problem solving methods to improve processes and eliminate Quality issues. The Quality Supervisor works closely with CI resources in the site to drive overall Lean and Quality improvements. In addition, as a contributor to Quality System compliance, the Quality Supervisor supports the site to ensure the Quality System adheres to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other regulatory standards, as applicable. Relocation assistance available What You'll do as Supervisor Quality Engineering Lead assigned Quality team focused on overall manufacturing/servicing quality improvement for key internal and customer facing metrics. Lead assigned Quality team focused on internal production quality by improving component and process non conformances; production line DPU (defect per unit); production FPY (first pass yield). Lead assigned Quality team to improve customer facing and internal product/service and process quality key metrics through robust data analysis and improvement/problem solving projects. Ensure robust production and process controls that are in alignment with production and Lean strategies. Align production product and service quality improvement to supplier improvement strategies and tactics. Establish individual and team objectives to attain key metric performance and ensure alignment to the overall Quality strategy. Lead the Team's talent development processes and knowledge development. Assume other duties as assigned. The Experience, Skills, and Abilities Needed Required: Bachelor's Degree (Engineering or related technical field) with minimum 5 years of Quality Engineering experience Minimum 5 years of experience working within a regulated or certified Quality Management System Minimum 3 years of experience with supplier quality Minimum 3 years of experience in Lean methods Minimum 3 years supervising/leading employees Preferred: Minimum 5 years of experience in healthcare, medical device, or other regulated industry ASQ, QSR, or familiarity with QSR/GMP regulations Other: Customer Focused: Demonstrates a “Customer first” mindset, responds with a sense of urgency Teamwork: Collaborates with others, works in a professional manner to support team actions Results: Effectively manages work tasks, is detail oriented and strives for continuous improvement, ability to analyze technical issues, ability to cope with change and shifting priorities Communication: Constructs clear written communication. Keeps manager and co-workers informed Job Knowledge: PC experience and working familiarity of common desktop applications including Excel, Visio, Minitab, and Word Initiative/Leadership: Takes ownership of task and projects and seeks clarification if unsure of direction Ability to analyze and interpret data; utilize problem solving methodologies and drive process improvements What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future. Here is a brief overview of what we offer: Market competitive pay Extensive paid time off and (9) added holidays Excellent healthcare, dental, and vision benefits Long/short term disability coverage 401(K) with company match Maternity and parental leave Additional add on benefits/discounts for programs such as pet insurance Tuition reimbursement and continued educational programs Excellent opportunities for advancement in a stable long-term career #LI-HT Pay range for this opportunity is $90,737.50 - $117,425.00. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc. STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits Open until position is filled. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
    $90.7k-117.4k yearly 55d ago
  • Senior Quality Systems Specialist (Mentor, OH, US, 44060)

    Steris Corporation 4.5company rating

    Mentor, OH jobs

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The Senior Quality Specialist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This role manages document control transactions, site record retention, calibration and inspection activities. In addition, the Senior Quality Specialist will lead Customer complaint, CAPA and NCR investigations, manage site audit activities, support supplier quality and customer assessments and lead risk management activities where appropriate. This role may also track and trend quality data and support a site's Management Review process. Duties * Manage the document control processes for the site. * Lead Customer complaint investigations and ensure complete complaint documentation. * Lead CAPA and NCR investigations and ensure proper documentation. * Manage the DHR and batch record release process. * Manage record retention practices within the site. * Coordinate site calibration activities and recordkeeping. * Manage site audit activities and recordkeeping. * Support supplier quality and Customer assessment activities. * Track, trend and analyze Quality data. * Support targeted Lean activities. * Complete other duties as assigned. The Experience, Skills and Abilities Needed Required: * Bachelor's degree required in technical fields (i.e. Engineering, Chemistry, Biology). * Minimum five (5) years of experience in a regulated industry (i.e. FDA/ISO 13485) * Knowledge of standard quality analysis tools (Problem Solving/Root Cause Analysis) Preferred: * Certification: ASQ, QSR, or AAMI certification preferred. What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future. Here is a brief overview of what we offer: * Market Competitive Pay * Extensive Paid Time Off and (9) added Holidays * Excellent Healthcare, Dental and Vision Benefits * Long/Short Term Disability Coverage * 401(k) with a company match * Maternity and Paternity Leave * Additional add-on benefits/discounts for programs such as Pet Insurance * Tuition Reimbursement and continued education programs * Excellent opportunities for advancement in a stable long-term career #LI-KL1 Pay range for this opportunity is $78,200.00 - $101,200.00. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc. STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits Open until position is filled. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
    $78.2k-101.2k yearly 30d ago
  • Senior Quality Systems Specialist

    Steris 4.5company rating

    Ohio jobs

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The Senior Quality Specialist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This role manages document control transactions, site record retention, calibration and inspection activities. In addition, the Senior Quality Specialist will lead Customer complaint, CAPA and NCR investigations, manage site audit activities, support supplier quality and customer assessments and lead risk management activities where appropriate. This role may also track and trend quality data and support a site's Management Review process. Duties • Manage the document control processes for the site. • Lead Customer complaint investigations and ensure complete complaint documentation. • Lead CAPA and NCR investigations and ensure proper documentation. • Manage the DHR and batch record release process. • Manage record retention practices within the site. • Coordinate site calibration activities and recordkeeping. • Manage site audit activities and recordkeeping. • Support supplier quality and Customer assessment activities. • Track, trend and analyze Quality data. • Support targeted Lean activities. • Complete other duties as assigned. The Experience, Skills and Abilities Needed Required: • Bachelor's degree required in technical fields (i.e. Engineering, Chemistry, Biology). • Minimum five (5) years of experience in a regulated industry (i.e. FDA/ISO 13485) • Knowledge of standard quality analysis tools (Problem Solving/Root Cause Analysis) Preferred: • Certification: ASQ, QSR, or AAMI certification preferred. What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future. Here is a brief overview of what we offer: • Market Competitive Pay • Extensive Paid Time Off and (9) added Holidays • Excellent Healthcare, Dental and Vision Benefits • Long/Short Term Disability Coverage • 401(k) with a company match • Maternity and Paternity Leave • Additional add-on benefits/discounts for programs such as Pet Insurance • Tuition Reimbursement and continued education programs • Excellent opportunities for advancement in a stable long-term career #LI-KL1 Pay range for this opportunity is $78,200.00 - $101,200.00. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc. STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits Open until position is filled. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
    $78.2k-101.2k yearly 55d ago
  • Senior Manager, Quality Packaging Engineer

    McKesson 4.6company rating

    Buna, TX jobs

    McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve - we care. What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow's health today, we want to hear from you. We are seeking a highly skilled and strategic Senior Manager, Quality Packaging Engineer, to lead the development, validation, and implementation of cold chain packaging solutions across our distribution network. This role ensures that all temperature-sensitive products are packaged and transported in compliance with industry standards and internal quality requirements. Key Responsibilities Oversee a team responsible for the design, validation, and deployment of new and existing cold chain packaging solutions while ensuring appropriate change management. Lead a team to support network-wide changes and initiatives related to cold chain packaging and transportation controls. Collaborate cross-functionally with Enterprise Quality, Logistics, Operations, and external packaging solution providers to ensure alignment and successful implementation of new or revised packaging solutions. Monitor and ensure correct packaging solutions are utilized at Distribution Centers (DCs). Manage vendor relationships and evaluate new technologies and materials. Lead updates and maintenance of SOPs and work instructions related to cold chain packaging. Provides coaching, mentoring, and performance management to team members, fostering a culture of continuous improvement and innovation. Champions talent development and succession planning within the packaging team. Minimum Requirement Degree or equivalent experience. Typically requires 9+ years of professional experience and 1+ years of supervisory and/or management experience. Education Bachelor's degree in engineering, Life Sciences, or a related field (master's preferred). Critical Skills 8+ years of experience in Engineering or Quality roles, preferably in pharmaceutical, biotech, or food industries. 3+ years of experience with direct responsibility for overseeing cold chain packaging programs Strong knowledge of ISTA standards and validation protocols. Proven experience managing cross-functional projects and driving network-wide initiatives. Excellent communication, organizational, and leadership skills. Experience with SOP development and regulatory compliance. Leadership Experience Requirements Minimum of 5-7 years of progressive leadership experience, preferably within pharmaceutical or life sciences packaging, with a focus on cold chain logistics. Proven track record of leading cross-functional teams in a regulated environment. Demonstrated ability to develop and execute strategic initiatives while managing operational priorities. Specialized Knowledge & Skills Knowledge of FDA and other regulatory agencies. Knowledge of wholesale distribution and/or pharmaceutical manufacturing. Excellent written and verbal communication skills. Strong analytical skills. Working Conditions Environment (Office, warehouse, etc.) Able to travel 40% of the time. Remote work environment - Work from Home. Physical Requirements (Lifting, standing, etc.) Using keyboard/laptop 8 hours a day Candidates must be authorized to work in USA. Sponsorship is not available for this role. We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, please click here. Our Base Pay Range for this position $109,500 - $182,500 McKesson is an Equal Opportunity Employer McKesson provides equal employment opportunities to applicants and employees and is committed to a diverse and inclusive environment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age or genetic information. For additional information on McKesson's full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page. Join us at McKesson!
    $109.5k-182.5k yearly Auto-Apply 55d ago
  • Senior Quality Engineering Lead (Mentor, OH, US, 44060)

    Steris Corporation 4.5company rating

    Mentor, OH jobs

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The Quality Engineering Supervisor leads a team of quality engineers, technicians and inspectors focused on process and product quality improvement for multiple production lines/values streams. This role has responsibility for incoming product/component inspection, NCR investigation, production quality, and final QC inspection/testing. The Quality Engineering Supervisor has responsibility for internal and customer facing key metric performance for assigned production lines/value streams. This role is responsible for the hiring, development, and overall management of his/her Quality team. This individual develops and manages work assignments, analyzes, and trends Quality performance data and utilizes problem solving methods to improve processes and eliminate Quality issues. The Quality Supervisor works closely with CI resources in the site to drive overall Lean and Quality improvements. In addition, as a contributor to Quality System compliance, the Quality Supervisor supports the site to ensure the Quality System adheres to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other regulatory standards, as applicable. Relocation assistance available What You'll do as Supervisor Quality Engineering * Lead assigned Quality team focused on overall manufacturing/servicing quality improvement for key internal and customer facing metrics. * Lead assigned Quality team focused on internal production quality by improving component and process non conformances; production line DPU (defect per unit); production FPY (first pass yield). * Lead assigned Quality team to improve customer facing and internal product/service and process quality key metrics through robust data analysis and improvement/problem solving projects. * Ensure robust production and process controls that are in alignment with production and Lean strategies. * Align production product and service quality improvement to supplier improvement strategies and tactics. * Establish individual and team objectives to attain key metric performance and ensure alignment to the overall Quality strategy. * Lead the Team's talent development processes and knowledge development. * Assume other duties as assigned. The Experience, Skills, and Abilities Needed Required: * Bachelor's Degree (Engineering or related technical field) with minimum 5 years of Quality Engineering experience * Minimum 5 years of experience working within a regulated or certified Quality Management System * Minimum 3 years of experience with supplier quality * Minimum 3 years of experience in Lean methods * Minimum 3 years supervising/leading employees Preferred: * Minimum 5 years of experience in healthcare, medical device, or other regulated industry * ASQ, QSR, or familiarity with QSR/GMP regulations Other: * Customer Focused: Demonstrates a "Customer first" mindset, responds with a sense of urgency * Teamwork: Collaborates with others, works in a professional manner to support team actions * Results: Effectively manages work tasks, is detail oriented and strives for continuous improvement, ability to analyze technical issues, ability to cope with change and shifting priorities * Communication: Constructs clear written communication. Keeps manager and co-workers informed * Job Knowledge: PC experience and working familiarity of common desktop applications including Excel, Visio, Minitab, and Word * Initiative/Leadership: Takes ownership of task and projects and seeks clarification if unsure of direction * Ability to analyze and interpret data; utilize problem solving methodologies and drive process improvements What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future. Here is a brief overview of what we offer: * Market competitive pay * Extensive paid time off and (9) added holidays * Excellent healthcare, dental, and vision benefits * Long/short term disability coverage * 401(K) with company match * Maternity and parental leave * Additional add on benefits/discounts for programs such as pet insurance * Tuition reimbursement and continued educational programs * Excellent opportunities for advancement in a stable long-term career #LI-HT Pay range for this opportunity is $90,737.50 - $117,425.00. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc. STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits Open until position is filled. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
    $90.7k-117.4k yearly 12d ago
  • Senior Quality Engineering Lead

    Steris 4.5company rating

    Ohio jobs

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The Quality Engineering Supervisor leads a team of quality engineers, technicians and inspectors focused on process and product quality improvement for multiple production lines/values streams. This role has responsibility for incoming product/component inspection, NCR investigation, production quality, and final QC inspection/testing. The Quality Engineering Supervisor has responsibility for internal and customer facing key metric performance for assigned production lines/value streams. This role is responsible for the hiring, development, and overall management of his/her Quality team. This individual develops and manages work assignments, analyzes, and trends Quality performance data and utilizes problem solving methods to improve processes and eliminate Quality issues. The Quality Supervisor works closely with CI resources in the site to drive overall Lean and Quality improvements. In addition, as a contributor to Quality System compliance, the Quality Supervisor supports the site to ensure the Quality System adheres to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other regulatory standards, as applicable. Relocation assistance available What You'll do as Supervisor Quality Engineering Lead assigned Quality team focused on overall manufacturing/servicing quality improvement for key internal and customer facing metrics. Lead assigned Quality team focused on internal production quality by improving component and process non conformances; production line DPU (defect per unit); production FPY (first pass yield). Lead assigned Quality team to improve customer facing and internal product/service and process quality key metrics through robust data analysis and improvement/problem solving projects. Ensure robust production and process controls that are in alignment with production and Lean strategies. Align production product and service quality improvement to supplier improvement strategies and tactics. Establish individual and team objectives to attain key metric performance and ensure alignment to the overall Quality strategy. Lead the Team's talent development processes and knowledge development. Assume other duties as assigned. The Experience, Skills, and Abilities Needed Required: Bachelor's Degree (Engineering or related technical field) with minimum 5 years of Quality Engineering experience Minimum 5 years of experience working within a regulated or certified Quality Management System Minimum 3 years of experience with supplier quality Minimum 3 years of experience in Lean methods Minimum 3 years supervising/leading employees Preferred: Minimum 5 years of experience in healthcare, medical device, or other regulated industry ASQ, QSR, or familiarity with QSR/GMP regulations Other: Customer Focused: Demonstrates a “Customer first” mindset, responds with a sense of urgency Teamwork: Collaborates with others, works in a professional manner to support team actions Results: Effectively manages work tasks, is detail oriented and strives for continuous improvement, ability to analyze technical issues, ability to cope with change and shifting priorities Communication: Constructs clear written communication. Keeps manager and co-workers informed Job Knowledge: PC experience and working familiarity of common desktop applications including Excel, Visio, Minitab, and Word Initiative/Leadership: Takes ownership of task and projects and seeks clarification if unsure of direction Ability to analyze and interpret data; utilize problem solving methodologies and drive process improvements What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future. Here is a brief overview of what we offer: Market competitive pay Extensive paid time off and (9) added holidays Excellent healthcare, dental, and vision benefits Long/short term disability coverage 401(K) with company match Maternity and parental leave Additional add on benefits/discounts for programs such as pet insurance Tuition reimbursement and continued educational programs Excellent opportunities for advancement in a stable long-term career #LI-HT Pay range for this opportunity is $90,737.50 - $117,425.00. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc. STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits Open until position is filled. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
    $90.7k-117.4k yearly 55d ago
  • Quality Systems Specialist - Weekend Shift (Mentor, OH, US, 44060)

    Steris Corporation 4.5company rating

    Mentor, OH jobs

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The Quality Specialist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This role coordinates document control transactions, site record retention, calibration and inspection activities. In addition, the Quality Specialist will facilitate Customer complaint investigations, assist in audit coordination, support supplier quality and customer assessments and support risk management activities where appropriate. This role may also track and trend Quality data and support the site Management Review process. This a weekend shift. Friday - Sunday; 6:00am-6:00pm. What You'll Do as a Quality Systems Specialist Complete document control transactions. Manage Customer complaint investigations and complete complaint documentation. Facilitate CAPA and NCR investigations and may coordinate investigation documentation. Review DHR's and support batch record release. Manage record retention practices within the site. Manage site calibration activities and recordkeeping. Support site inspection activities and recordkeeping. Coordinate internal and external audits. Support supplier quality and Customer assessment activities. Track and trend site Quality data. Support targeted Lean activities. Complete other duties as assigned. The Experience, Skills and Abilities Needed Required: * Associate degree * Minimum two (2) years experience in quality in a regulated industry (i.e FDA/ISO 13485). * PC experience and working familiarity with MS application such as Word, Excel, Outlook and Teams. What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future. Here is a brief overview of what we offer: * Market Competitive Pay * Extensive Paid Time Off and (9) added Holidays * Excellent Healthcare, Dental and Vision Benefits * Long/Short Term Disability Coverage * 401(k) with a company match * Maternity and Paternity Leave * Additional add-on benefits/discounts for programs such as Pet Insurance * Tuition Reimbursement and continued education programs * Excellent opportunities for advancement in a stable long-term career #LI-KL1 Pay range for this opportunity is $58,012.50 - $71,662.50. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc. STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits Open until position is filled. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
    $58k-71.7k yearly 30d ago
  • Quality Systems Specialist - Weekend Shift

    Steris 4.5company rating

    Ohio jobs

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The Quality Specialist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This role coordinates document control transactions, site record retention, calibration and inspection activities. In addition, the Quality Specialist will facilitate Customer complaint investigations, assist in audit coordination, support supplier quality and customer assessments and support risk management activities where appropriate. This role may also track and trend Quality data and support the site Management Review process. This a weekend shift. Friday - Sunday; 6:00am-6:00pm. What You'll Do as a Quality Systems Specialist Complete document control transactions. Manage Customer complaint investigations and complete complaint documentation. Facilitate CAPA and NCR investigations and may coordinate investigation documentation. Review DHR's and support batch record release. Manage record retention practices within the site. Manage site calibration activities and recordkeeping. Support site inspection activities and recordkeeping. Coordinate internal and external audits. Support supplier quality and Customer assessment activities. Track and trend site Quality data. Support targeted Lean activities. Complete other duties as assigned. The Experience, Skills and Abilities Needed Required: Associate degree Minimum two (2) years experience in quality in a regulated industry (i.e FDA/ISO 13485). PC experience and working familiarity with MS application such as Word, Excel, Outlook and Teams. What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future. Here is a brief overview of what we offer: • Market Competitive Pay • Extensive Paid Time Off and (9) added Holidays • Excellent Healthcare, Dental and Vision Benefits • Long/Short Term Disability Coverage • 401(k) with a company match • Maternity and Paternity Leave • Additional add-on benefits/discounts for programs such as Pet Insurance • Tuition Reimbursement and continued education programs • Excellent opportunities for advancement in a stable long-term career #LI-KL1 Pay range for this opportunity is $58,012.50 - $71,662.50. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc. STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits Open until position is filled. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
    $58k-71.7k yearly 51d ago
  • Quality Control Laboratory Supervisor (Mentor, OH, US, 44060)

    Steris Corporation 4.5company rating

    Mentor, OH jobs

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The QC Laboratory Supervisor is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This position is responsible for all aspects of quality control within the organization including receiving, in-process, finished goods testing, scheduling resources, defining solutions to improve compliance, and provide key input to senior management on compliance in accordance with the requirements for ISO, FDA QSR, and STERIS policies. What You'll Do as a Quality Control Lab Supervisor * Supervises laboratory activities to ensure all products are tested in accordance with company policy and Good Laboratory Practices. * Supports NPD projects and completes all tasks related to the laboratory. * Serves as a contact point for outside vendors, consultants and auditors. * Assist with developing test methodologies and procedures. * Assists / trains Lab Techs and Specialist. * Works with QS on internal and external audits and audit training. * Assists with developing and validating methods. The Experience, Skills and Abilities Needed Required: * Bachelor degree * Minimum eight (8) years relevant lab testing in a regulated environment (i.e. FDA/ISO 13485). * Minimum two (2) years supervisory/leadership experience. * Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis), Root Cause Analysis, and Statistics. Preferred: * Demonstrated experience with setting priorities and working with planning and scheduling teams in order to meet shipping goals. What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future. Here is a brief overview of what we offer: * Market Competitive Pay * Extensive Paid Time Off and (9) added Holidays * Excellent Healthcare, Dental and Vision Benefits * Long/Short Term Disability Coverage * 401(k) with a company match * Maternity and Paternity Leave * Additional add-on benefits/discounts for programs such as Pet Insurance * Tuition Reimbursement and continued education programs * Excellent opportunities for advancement in a stable long-term career #LI-KL1 Pay range for this opportunity is $78,200.00 - $101,200.00. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc. STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits Open until position is filled. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
    $78.2k-101.2k yearly 30d ago
  • QC Laboratory Supervisor (Mentor, OH, US, 44095)

    Steris Corporation 4.5company rating

    Mentor, OH jobs

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The QC Laboratory Supervisor is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This position is responsible for all aspects of quality control within the organization including receiving, in-process, finished goods testing, scheduling resources, defining solutions to improve compliance, and provide key input to senior management on compliance in accordance with the requirements for ISO, FDA QSR, and STERIS policies. What You'll Do as a QC Laboratory Supervisor Supervises laboratory activities to ensure all products are tested in accordance with company policy and Good Laboratory Practices. Supports NPD projects and completes all tasks related to the laboratory. Serves as a contact point for outside vendors, consultants and auditors. Assist with developing test methodologies and procedures. Assists / trains Lab Techs and Specialist. Works with QS on internal and external audits and audit training. Assists with developing and validating methods. What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future. Here is a brief overview of what we offer: * Market Competitive Pay ⦁ Extensive Paid Time Off and (9) added Holidays * Excellent Healthcare, Dental and Vision Benefits * Long/Short Term Disability Coverage * 401(k) with a company match * Maternity and Paternity Leave * Additional add-on benefits/discounts for programs such as Pet Insurance * Tuition Reimbursement and continued education programs * Excellent opportunities for advancement in a stable long-term career #LI-KL1 The Experience, Skills and Abilities Needed Required: * Bachelor degree * Minimum eight (8) years relevant lab testing in a regulated environment (i.e. FDA/ISO 13485). * Minimum two (2) years supervisory/leadership experience. * Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis), Root Cause Analysis, and Statistics. * Knowledge of HPLC Pay range for this opportunity is $78,200.00 - $96,600.00. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc. STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits Open until position is filled. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
    $78.2k-96.6k yearly 27d ago
  • Quality Control Laboratory Supervisor

    Steris 4.5company rating

    Ohio jobs

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The QC Laboratory Supervisor is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This position is responsible for all aspects of quality control within the organization including receiving, in-process, finished goods testing, scheduling resources, defining solutions to improve compliance, and provide key input to senior management on compliance in accordance with the requirements for ISO, FDA QSR, and STERIS policies. What You'll Do as a Quality Control Lab Supervisor Supervises laboratory activities to ensure all products are tested in accordance with company policy and Good Laboratory Practices. Supports NPD projects and completes all tasks related to the laboratory. Serves as a contact point for outside vendors, consultants and auditors. Assist with developing test methodologies and procedures. Assists / trains Lab Techs and Specialist. Works with QS on internal and external audits and audit training. Assists with developing and validating methods. The Experience, Skills and Abilities Needed Required: Bachelor degree Minimum eight (8) years relevant lab testing in a regulated environment (i.e. FDA/ISO 13485). Minimum two (2) years supervisory/leadership experience. Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis), Root Cause Analysis, and Statistics. Preferred: Demonstrated experience with setting priorities and working with planning and scheduling teams in order to meet shipping goals. What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future. Here is a brief overview of what we offer: • Market Competitive Pay • Extensive Paid Time Off and (9) added Holidays • Excellent Healthcare, Dental and Vision Benefits • Long/Short Term Disability Coverage • 401(k) with a company match • Maternity and Paternity Leave • Additional add-on benefits/discounts for programs such as Pet Insurance • Tuition Reimbursement and continued education programs • Excellent opportunities for advancement in a stable long-term career #LI-KL1 Pay range for this opportunity is $78,200.00 - $101,200.00. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc. STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits Open until position is filled. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
    $78.2k-101.2k yearly 55d ago
  • QC Laboratory Supervisor

    Steris 4.5company rating

    Ohio jobs

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The QC Laboratory Supervisor is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. This position is responsible for all aspects of quality control within the organization including receiving, in-process, finished goods testing, scheduling resources, defining solutions to improve compliance, and provide key input to senior management on compliance in accordance with the requirements for ISO, FDA QSR, and STERIS policies. What You'll Do as a QC Laboratory Supervisor Supervises laboratory activities to ensure all products are tested in accordance with company policy and Good Laboratory Practices. Supports NPD projects and completes all tasks related to the laboratory. Serves as a contact point for outside vendors, consultants and auditors. Assist with developing test methodologies and procedures. Assists / trains Lab Techs and Specialist. Works with QS on internal and external audits and audit training. Assists with developing and validating methods. What STERIS Offers We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future. Here is a brief overview of what we offer: • Market Competitive Pay ⦁ Extensive Paid Time Off and (9) added Holidays • Excellent Healthcare, Dental and Vision Benefits • Long/Short Term Disability Coverage • 401(k) with a company match • Maternity and Paternity Leave • Additional add-on benefits/discounts for programs such as Pet Insurance • Tuition Reimbursement and continued education programs • Excellent opportunities for advancement in a stable long-term career #LI-KL1 The Experience, Skills and Abilities Needed Required: Bachelor degree Minimum eight (8) years relevant lab testing in a regulated environment (i.e. FDA/ISO 13485). Minimum two (2) years supervisory/leadership experience. Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis), Root Cause Analysis, and Statistics. Knowledge of HPLC Pay range for this opportunity is $78,200.00 - $96,600.00. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc. STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits Open until position is filled. STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
    $78.2k-96.6k yearly 25d ago
  • Staff Quality Engineer

    Johnson & Johnson 4.7company rating

    Cincinnati, OH jobs

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: R&D Product Development Job Sub Function: Biomedical Engineering Job Category: Scientific/Technology All Job Posting Locations: Cincinnati, Ohio, United States of America Job Description: Johnson & Johnson is currently recruiting for a Staff Quality Engineer! This position will be located in Cincinnati, Ohio. Position Summary: * This position will support New Product Development or Lifecycle Engineering within the Energy Quality organization, based in Cincinnati, OH * This position will support the Energy franchise that may include Harmonic, Advanced Bipolar, Capital and Megadyne. * Defines, leads and implements state-of-the-art quality engineering focus and improvements in design and development of products, and in transfer and steady state phases of manufacturing operations. * Influences the company's business, tactical directions, and financial results through a sharing of technical expertise. Performs complex design analysis and provides input or approval for detailed design specifications, tooling, fabrication, and testing. * At this level the role has increased responsibility including, but not limited to, additional skills, multiple lines/products, diverse teams, etc. Staff Quality Engineer Duties * Supports the continuous improvement of quality systems to facilitate business and quality objectives, and compliance review and resolution processes. * Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business. * Oversees the quality engineering group to implement engineering and quality systems, and regulatory compliance strategies and objectives. * Conducts basic technical design reviews and facilitates the implementation and utilization of quality tools within research and development and new product development. * Researches and compiles worldwide regulatory and technical standards for shift in design related quality trends. * Directs the work assignments of engineers to support effective quality engineering processes at all levels and throughout the engineering organization. * Oversees engineers in development and deployment of innovative quality engineering tools, techniques and systems. * Oversees the implementation of world with focus on business results including prevention and detection of defects at earliest phase of product design, continuous improvement and customer satisfaction. * Provides support to Johnson and Johnson process excellence initiatives including six sigma, design excellence, and lean thinking. * Oversees engineering operations, scientific evaluations of new products, technology concepts and development. * Purchases or designs equipment that meets health, safety and environmental standards set by the company. * Performs design reviews and pre-validation assessments to ensure the safe and environmentally sound startup of new processes. * Assures compliance with all local government and company regulations, policies and procedures. * Provides statistical support for design of experiments, sampling plans, capability assessments, and hypothesis tests. * Researches and reports on competitors' design strengths and weaknesses. * Provides technical expertise across a broad range of engineering areas and methodologies. * Leads and oversees the activities of engineers and support staff. * Responsible for communicating business related issues or opportunities to next management level. * For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable. * Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. * Performs other duties assigned as needed. * May support technical training (i.e. statistics and quality methods) and teaching/mentoring of other Required Experience and Skills: * A minimum of 6 years of work experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) or veterans with leadership experience * Advanced knowledge of Quality Engineering/Scientific methods and techniques * Applied statistics of growing complexity * Test method development, statistics, and reliability * Experience working within a team, acquiring feedback, negotiating, and training * Understand new concepts quickly, research and maintain ongoing learning of industry regulations * Fundamental technical understanding of manufacturing equipment and processes * Experience implementing and/or maintaining production and process controls using appropriate techniques (for example: process capability measures, statistical process controls, and process performance metrics) Preferred Experience & Skills: * Knowledge of: Regulatory compliance, GMPs, MDR, 510K (Pre-market Notification), PMA (Pre-market Approval), and Government, trade association, industry & medical publications * An ASQ certification (CQE, CQM, CRE or CQA) * Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification * Project management (supporting multiple projects at a time) and the ability to work with simultaneous priorities in a matrixed environment * Experience with Risk Management (ISO 14971), Medical Device Quality Management Systems (ISO 13485) and Advanced Quality Systems (AQS) * Apply and execute Quality System processes (CAPA, NCR, Risk Management, Design Control, Change Control) Other: * This position is located in Cincinnati, OH and has up to 10% of both domestic and international travel. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via *******************/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : $91,000-$147,200 USD$ Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
    $91k-147.2k yearly Auto-Apply 20d ago

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