Principal Quality Engineer

Position Description

Principal Quality Engineer for Medtronic, Inc. in Grand Rapids, MI. 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.

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.