Senior Quality Engineer, Medical Devices - Onsite

MED Medtronic Inc; 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

Tuition assistance/reimbursement

Employee Stock Purchase Plan

Job summary

Medtronic, Inc. in Grand Rapids, MI seeks a Principal Quality Engineer to oversee quality for finished medical devices, support GMP/QSR/ISO 13485 compliance, and drive CAPA and process improvements. You will coordinate DOE, quality systems, and analytics to ensure product conformity.

Onsite role in Grand Rapids, four days per week, with responsabilites spanning audits, PFMEA, and V&V protocols. Strong regulatory knowledge and data-driven decision making are essential.

Qualifications

• Master’s degree in Biomedical, Mechanical, Industrial Engineering, Engineering Management or related field; 5+ years of quality/packaging engineering experience.
• Bachelor’s degree in Biomedical, Mechanical, Industrial Engineering, Engineering Management or related field; 7+ years of experience in quality engineering.

Responsibilities

• Coordinate Quality Engineering for medical device components and ensure finished goods meet specifications.
• Support GMP, QSR, ISO 13485, EU MDR compliance and regulatory requirements.
• Lead audits, CAPA, PFMEA, RCA and risk assessments; drive process improvements.

Skills

GMP

QSR 21 CFR 820

ISO 13485

EU MDR

FTQ principles

Education

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

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

Tools

Minitab

Power BI

Job description

Medtronic, Inc. in Grand Rapids, MI seeks a Principal Quality Engineer to oversee quality for finished medical devices, support GMP/QSR/ISO 13485 compliance, and drive CAPA and process improvements. You will coordinate DOE, quality systems, and analytics to ensure product conformity.

Onsite role in Grand Rapids, four days per week, with responsabilites spanning audits, PFMEA, and V&V protocols. Strong regulatory knowledge and data-driven decision making are essential.