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We anticipate the application window for this opening will close on - 26 Dec 2025

Position Description:

Quality Systems Manager for Medtronic, Inc. located in Northridge, CA. Provide expertise, guide, and ensure technical rigor in all aspects of Quality Engineering related to manufacturing Site Quality. Plan, coordinate, and execute Medical Device standards activities to ensure the safety and reliability of Medtronic Mini-Med products from concept to end of life. Support standards programs and systems, including both pre-market and post-market product support. Navigate various data analytical tools to deep dive into defect trending and reduce nonconformance. Navigate various standards activities to include standards compliance assessments, identifying applicable standards and portions of standards. Collaborate with the development team to proactively identify and classify risks, ensuring the appropriate translation of standards clauses into product and system requirements, and implementing effective controls to mitigate potential issues. Support various process changes, design changes, new materials and new component engineering change orders. Navigate various government and industry standards for the development and use of medical devices including FDA QSR (Quality Systems Regulations), ISO13485, ISO14971, ISO11135, ISO11737, MDD (Medical Device Directives) 93/42, AIMDD (Active Implantable Medical Device Directives) 90/385, and EU MDR (European Union Medical Device Regulations). Utilize Good Manufacturing Practices (GMP) and risk management activities using FMEA (Failure Mode Effect Analysis). Coordinate Design Control, Design Verification and Process Validation. Lead and oversee root cause investigations, ensuring effective coordination and implementation of Corrective and Preventive Actions (CAPA). Provide for Test method Development, Remediation and Validation. Utilize Excel, Power BI tool, and Minitab for data analytics, process variation, and capability analysis. Relocation assistance not available for this position. #LI-DNI

Basic Qualifications:

Master’s Degree in Mechanical, Biomedical or Industrial Engineering or related engineering field, and 2 years of experience as a quality engineer or related occupation. Must possess at least two (2) years’ experience with each of the following: Supporting standards programs and systems for both pre-market and post-market product support; Excel, Power BI tool, Minitab for data analytics, process variation, and capability analysis; Supporting process changes, design changes, new materials and new component engineering change orders; FDA QSR, ISO13485, ISO14971, ISO11135, ISO11737, MDD 93/42, AIMDD 90/385, and EU MDR; GMP and risk management activities using FMEA; Design Control, Design Verification, and Process Validation; Root cause investigations and CAPA; and Test method Development, Remediation and Validation.

Salary: $164,000 to $211,200 per year

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page\_name=signon&co\_num=30601&co\_affid=medtronic)

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will…

+ **Build** a better future, amplifying your impact on the causes that matter to you and the world

+ **Grow** a career reflective of your passion and abilities

+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest:

**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

**Better outcomes for our world** . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .

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