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Principal Quality Engineer at Medtronic - ApplyBlast

Principal Quality Engineer

Medtronic

3 days ago

3.7 on Glassdoor

Grand Rapids, Michigan, United States

Onsite

Full Time

Senior

1 applicant

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About this role

The Principal Quality Engineer at Medtronic in Grand Rapids, MI, supports manufacturing operations for finished medical devices by ensuring compliance with product specifications, regulatory requirements, and customer needs. The role involves coordinating quality engineering for medical device components, leveraging GMP standards, and navigating regulations like 21 CFR Part 820, ISO 13485, and EU MDR. The position requires onsite work at least 4 days a week, with relocation assistance not available.

Responsibilities

Support manufacturing operations and evaluate compliance of materials and processes
Coordinate Quality Engineering for medical device components and finished goods
Conduct Risk Assessments, PHA, PFMEA, and manage Non-Conformances and CAPA

Skills

Qualifications

Master’s degree in Biomedical, Mechanical, Industrial Engineering, Engineering Management or related engineering fieldBachelor’s degree in Biomedical, Mechanical, Industrial Engineering, Engineering management or related engineering field