Principal Quality Engineer

• Position Description:
• Responsible for products in the form of finished medical devices by supporting manufacturing operations and evaluating compliance of materials and processes with product specifications, regulatory requirements, and customer requirements. Coordinate Quality Engineering for medical device components, ensuring that all finished good and processes meet specifications. Leverage Good Manufacturing Practices (GMP) standards, navigate government and medical device regulations to include 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, EU Medical Device Regulation (MDR), and State of the Art (SOTA). Coordinate and support internal and external audits conducted at the facility. Conduct Risk Assessments, Preliminary Hazard Analysis (PHA), and Process Failure Modes and Effects Analysis (PFMEA). Responsible for Non-Conformances, Complaints, and Corrective and Preventive Actions (CAPA). Utilize Process Improvement tools, including Define, Measure, Analyze, Improve, and Control (DMAIC), Root Cause Analysis (RCA), 5 Whys, Fishbone, and cause mapping. Contribute to Business Value stream Mapping (VSM) initiatives and support process flow strategy areas to drive quality excellence and process compliant stability. Coordinate Design of Experiments (DOE) methods for process development and statistical analysis tools for process capability (Cpk/Ppk), ANOVA, Gage Repeatability and Reproducibility (Gage R&R), Attribute Agreement Analysis, and Test Method Validation (TMV). Coordinate V&V (verification and validation) protocols, including Installation Qualification, Operational Qualification, Performance Qualification (IQ, OQ, and PQ). Utilize analytical tools including Minitab and Power BI for statistical analysis and data-driven decision-making. Coordinate product lifecycle mgmt. efforts, including overseeing quality systems and authoring technical documentation. Leverage First Time Quality (FTQ) principles to enhance process improvement and drive strategic initiatives. Position is required to be onsite in Grand Rapids, MI – at least 4 days a week. Relocation assistance is not available for this position. #LI-DNI.

NOTICE: Pursuant to 20 C.F.R. § 656.10, you are hereby notified that an Application for Permanent Employment Certification will be filed for the job opportunity below. Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer at the U.S. Department of Labor as follows:

• Certifying Officer
• U.S. Department of Labor
• Employment and Training Administration
• Office of Foreign Labor Certification
• 200 Constitution Avenue NW, Room N-5311
• Washington, DC 20210

• Basic Qualifications:
• Master’s degree in Biomedical, Mechanical, Industrial Engineering, Engineering Management or related engineering field and five (5) years of experience as a Quality or Packaging Engineer or related occupation in quality engineering;
• OR
• Bachelor’s degree in Biomedical, Mechanical, Industrial Engineering, Engineering management or related engineering field and seven (7) years of experience as a Quality or Packaging Engineer or related occupation in quality engineering.

• Must possess at least five (5) years’ experience with each of the following:
• GMP, 21 CFR Part 820 QSR, ISO 13485, EU MDR (or its predecessor), and SOTA; Risk Assessments, PHA, and PFMEA; Non-Conformances and CAPA; DMAIC, RCA, 5 Whys, Fishbone, cause mapping, and VSM; DOE, Cpk/Ppk, ANOVA, Gage R&R, Attribute Agreement Analysis, and TMV; Lean – Six Sigma; V&V protocols and IQ/OQ/PQ; Minitab and Power BI; Product lifecycle mgmt., including quality systems and authoring technical documentation; and FTQ principles.

The position is located at Medtronic, Inc., 620 Watson Street SW, Grand Rapids, MI 49504.

Salary: $121,000 to $181,200 per year

THIS POSITION QUALIFIES FOR THE MEDTRONIC EMPLOYEE REFERRAL BONUS PROGRAM AT THE LEVEL OF $1,000. Refer to the program guidelines located at myworkday.com/medtronic. Go to: Menu > Jobs Hub > Refer a Candidate

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:
• Use this link to hyperlink:

https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic