We anticipate the application window for this opening will close on - 11 Jul 2025.

Please make sure you read the following details carefully before making any applications. Position Description: Senior Quality Engineer for Medtronic, Inc., located in Jacksonville, FL. Provide quality manufacturing process solutions for Medtronic’s implantable and non-implantable medical devices. Partner with Manufacturing Engineering and Research & Development Engineering to assist in developing test methods, equipment acquisition for new product testing, design verification, process characterizations, Installation Qualifications, design reliability, and process capability. Conduct statistical analyses and work with policy stakeholders regarding risk-based sampling methodologies. Coordinate projects for cost-saving initiatives, including eliminating duplicate inspections and driving process improvements. Utilize Medical Device industry standards in accordance with 21 CFR Part 820, Part 11, GMP, ISO 13485, and ISO 14971. Perform Risk Management, Test Method Validation (TMV), and Design Validation. Coordinate Non-Conforming Material Reports (NCMR) for non-conforming material and provide product investigation, containment, and disposition activities. Utilize development protocols including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Special Process Validations, and Test Method Validations (TMV). Coordinate various Root Cause and Corrective & Preventive Actions (CAPA) programs. Collaborate with customer quality to perform assessments on manufacturing-related complaints using 21 CFR Part 803 and the Global complaints handling system (GCH). Basic Qualifications: Masters’ Degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or related engineering field with two (2) years of experience as a quality engineer or related occupation; OR Bachelor’s Degree in the same fields with five (5) years of relevant experience. Must possess at least two (2) years’ experience with each of the following: ISO 13485, ISO 14971, 21 CFR Part 820, Part 11, GMP, Risk Management, TMV, Design Validation, Process Validation, Design Verification, DHF and DMR, NCMR, Product Investigation, IQ/OQ/PQ, Root Cause and CAPA, 21 CFR Part 803, and GCH. Salary: $114,500 to $141,600 per year. Benefits: The following benefits and additional compensation are available to regular employees working 20+ hours per week: Health, Dental, Vision insurance, HSA, Healthcare FSA, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Well-being programs. All regular employees are eligible for Incentive plans, 401(k) with employer contribution, Short-term disability, Paid time off, Holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan, and Capital Accumulation Plan (subject to IRS minimums). Temporary employees are eligible for paid sick time and the Employee Stock Purchase Plan. Some benefits may not apply in Puerto Rico. Additional Information: Further details are available at: https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic Medtronic is a global leader in healthcare technology, dedicated to solving the most challenging health problems and improving lives through innovation and compassionate care.

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