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Sr. Supplier Quality Engineer

Lead supplier qualification and validation processes for medical device manufacturing
Minneapolis, Minnesota, United States
Senior
$121,400 – 145,200 USD / year
2 days ago
Minnesota Staffing

Minnesota Staffing

Minnesota Staffing appears to be a staffing agency, but the domain mn.gov suggests it is a government entity, which is confusing. Without more information, I cannot provide an accurate description.

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Sr. Supplier Quality Engineer

We anticipate the application window for this opening will close on 20 Oct 2025. Position Description: Sr. Supplier Quality Engineer for Medtronic, Inc. located in Minneapolis, MN. Responsible for communicating technical objectives between Medtronic and suppliers. Coordinate with cross-functional groups in supplier selection process. Developing and maintaining incoming inspection procedures, ensuring inspector trainings and qualifying parts for SOQ program. Responsible for Supplier Change process between Medtronic and Suppliers to evaluate and implement changes at Supplier. Responsible for Supplier and Medtronic CAPA (Corrective and Preventive Action) Supplier related Product and Process NCMR (Nonconforming Material Report) by working with the supplier to conduct root cause investigation, implement appropriate controls and perform effectiveness checks. Responsible for Supplier Maintenance and Controls, Supplier Audits, Quality Agreements, Quality Performance Reviews. Execute supplier and component qualification and validation including drafting, Control Plans, PPAP (Production Part Approval Process), Medtronic qualify plans/RIR (Receiving Inspection Requirements), and Gage R&R (Repeatability & Reproducibility), DOE (Design of Experiments), and GD&T (Geometric Dimensioning and Tolerancing). Coordinate equipment Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Validation, pFMEA (Process Failure Mode and Effects Analysis) and Risk Assessments of suppliers, Test Method Validations and Measurement System Analysis. Utilize failure investigation techniques, statistical quality controls, protocol & report preparation, and non-conforming product controls. Utilize GMP (Good Manufacturing Practices) for Class II and Class III medical devices to ensure quality products and outcomes. Navigate the complexities of various government and industry regulations to include FDA QSR 21 CFR 820, EU Medical Device Directive (EU MDD 93/42 EEC), ISO 13485, ISO 9001, and ISO 14971. Multiple positions available. Position is open to telecommuting from anywhere in the United States. Requires up to 25% travel to suppliers within the U.S. and internationally.

Basic Qualifications: Requires a Master’s degree in Mechanical, Biomedical, Industrial, Electrical, or Manufacturing Engineering, Engineering Technology, Technology Project Management or related engineering field, and two (2) years’ experience as a supplier, quality, or manufacturing engineer or related occupations; or Bachelor’s degree in Mechanical, Biomedical, Industrial, Electrical or Manufacturing Engineering, Engineering Technology, Technology Project Management, or related engineering field, and five (5) years’ experience as a supplier, quality, or manufacturing engineer or related occupations. Must possess at least two (2) years’ experience with each of the following: Supplier Change Process evaluation and implementation; CAPA, Supplier related Product and Process NCMR; Supplier Maintenance and Controls, Supplier Audits, Quality Agreements, and Quality Performance Reviews; Supplier and component qualifications and validations, including Control Plans, PPAP, RIR, Gage R&R, DOE, and GD&T IQ/OQ/PQ, Process Validation, pFMEA and Risk Assessments of suppliers, Test Method; Validations, and Measurement System Analysis; Failure investigation techniques, statistical quality controls, protocol & report preparation, and non-conforming product controls; GMP for Class II and Class III medical devices; FDA QSR 21 CFR 820, EU MDD 93/42 EEC, ISO 13485, ISO 9001 and ISO 14971.

Salary: $121,400 to $145,200 per year The position reports to Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432. 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.

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. 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. For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com

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Sr. Supplier Quality Engineer
Minneapolis, Minnesota, United States
$121,400 – 145,200 USD / year
Engineering
About Minnesota Staffing
Minnesota Staffing appears to be a staffing agency, but the domain mn.gov suggests it is a government entity, which is confusing. Without more information, I cannot provide an accurate description.