Sr. Quality Engineer (Finance)

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

Position Description:

Sr. 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 (Good Manufacturing Practices), ISO 13485, and ISO 14971. Perform Risk Mgmt., 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 to include 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. Coordinate with customer quality to perform assessments on Manufacturing related complaints using 21CFR Part 803 and Global complaints handling system (GCH). #LI-DNI.

Basic Qualifications:

Masters' Degree in Mechanical Engineering, Industrial Engineering or Biomedical Engineering or related engineering field and two (2) years of experience as a quality engineer or related occupation; OR Bachelors' Degree in Mechanical Engineering, Industrial Engineering or Biomedical Engineering or related engineering field and five (5) years of experience as a quality engineer or related occupation. Must possess at least two (2) years' experience with each of the following: ISO 13485, ISO 14971, 21 CFR Part 820, Part 11, and GMP; Risk Mgmt., TMV, Design Validation, Process Validation, and Design Verification; DHF and DMR; NCMR, Product Investigation; IQ/OQ/PQ; Root Cause and CAPA; 21CFR Part 803 and GCH.

Salary: $114,500 to $141,600 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