Senior Principal QA Engineer – Medical Devices & GMP Leader

Nextern; Maple Grove (MN); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Health Care Plan (Medical, Dental &amp

Retirement Plan with Company Match

Paid Time Off, Personal Days, AND...

Lifetime Membership Subsidy and Welln…

Life Insurance (Basic, Voluntary &

Job summary

Nextern, a medical device manufacturer, seeks an experienced Quality Engineer to own sustaining activities for commercial and investigational device manufacturing, ensuring GMP/GDP compliance and traceability across the QMS.

Responsibilities cover leading audits, CAPAs, nonconformances, and product lifecycle management systems, while collaborating with US and global teams to drive continuous quality improvements.

Qualifications

• Bachelor's degree in engineering or equivalent.
• 10+ years in medical device manufacturing.
• Experience with 21 CFR 820, ISO 13485 and GMP/GDP.
• Knowledge of ISO 14971 and risk management.
• Strong communication and leadership abilities.
• Familiarity with PLM software.

Responsibilities

• Support US manufacturing with up to 10% global site involvement.
• Lead core project activities: PFMEA, validation plans/reports.
• Draft, collaborate, and approve project deliverables and WOs.
• Coordinate and execute process output verification/validation.
• Maintain Device Master Records (DMR) and quality metrics.
• Own manufacturing/DHR review for complaint investigations.

Skills

Quality leadership

Process improvement

Regulatory compliance

Documentation

Education

Bachelor's Degree in engineering

Tools

Minitab

Windchill

Agile

Propel

MS Office

Job description

Nextern, a medical device manufacturer, seeks an experienced Quality Engineer to own sustaining activities for commercial and investigational device manufacturing, ensuring GMP/GDP compliance and traceability across the QMS.

Responsibilities cover leading audits, CAPAs, nonconformances, and product lifecycle management systems, while collaborating with US and global teams to drive continuous quality improvements.