Principal Quality Engineer - Medical Device GMP/QSR Expert

Regulatory Jobs; Grand Rapids (MI); On-site; USD 121,000 - 181,000; Full time

Benefits offered by this job

Health, Dental and Vision insurance

Health Savings Account

Education assistance

Employee Stock Purchase Plan

Paid time off

Paid holidays

401(k) with employer match

Job summary

Medtronic, Inc. in Grand Rapids, MI is seeking a Principal Quality Engineer to oversee quality for finished medical devices and to support manufacturing operations for regulatory compliance and product certification.

You will coordinate quality engineering activities, drive CAPA, risk management, and process improvements, and apply advanced statistical methods using Minitab and Power BI to ensure compliant, high-quality products.

Qualifications

• Master’s degree in Biomedical, Mechanical, Industrial Engineering, Engineering Management or related field with five years in quality engineering.
• OR Bachelor’s degree in Biomedical, Mechanical, Industrial Engineering, Engineering Management with seven years in quality engineering.
• Must have at least five years’ experience with GMP, 21 CFR Part 820 QSR, ISO 13485, EU MDR (or its predecessor), and SOTA.
• Experience with Risk Assessments, PHA, and PFMEA; Non-Conformances and CAPA.
• DMAIC, RCA, 5 Whys, Fishbone, and VSM experience; DOE, Cpk/Ppk, ANOVA, Gage R&R, TMV.
• Lean – Six Sigma familiarity; V&V protocols and IQ/OQ/PQ; Minitab and Power BI.
• Product lifecycle mgmt., including quality systems and authoring technical documentation.

Responsibilities

• Coordinate Quality Engineering for medical device components to meet specifications.
• Support manufacturing operations and evaluate regulatory compliance (21 CFR 820, ISO 13485).
• Coordinate internal and external audits at the facility and support process improvement.
• Lead risk assessments (PHA) and DFMEA/PFMEA activities and CAPA management.
• Apply DMAIC, RCA, and statistical tools (Minitab) to drive process capability (Cpk/Ppk).
• Develop DOE studies and manage V&V protocols (IQ/OQ/PQ) and documentation.

Skills

GMP & QSR

Risk Assessments (PHA, PFMEA)

CAPA & Non-Conformances

DMAIC & RCA

DOE & Statistics (Cpk/Ppk, ANOVA)

V&V IQ/OQ/PQ

Minitab & Power BI

Quality systems docs

Education

Master’s degree in Biomedical/Mechanical/Industrial Eng or related field

Bachelor’s degree in Biomedical/Mechanical/Industrial Eng or related field

Tools

Minitab

Power BI

Job description

Medtronic, Inc. in Grand Rapids, MI is seeking a Principal Quality Engineer to oversee quality for finished medical devices and to support manufacturing operations for regulatory compliance and product certification.

You will coordinate quality engineering activities, drive CAPA, risk management, and process improvements, and apply advanced statistical methods using Minitab and Power BI to ensure compliant, high-quality products.