Overview
Senior Quality Engineer – 253581 Jobs in Maple Grove, MN at Medix™
Title: Senior Quality Engineer – 253581
Company: Medix™
Location: Maple Grove, MN
We’re seeking an experienced Senior Quality Assurance Engineer to support manufacturing and product lifecycle quality activities within a fast-paced medical device environment. This role will partner cross-functionally with Operations, Engineering, and Regulatory teams to ensure compliance, drive continuous improvement, and support commercial manufacturing readiness.
Key Responsibilities:
- Lead CAPA, nonconformance investigations, and root cause analysis
- Support audits, inspection readiness, and quality system compliance
- Oversee supplier quality and incoming inspection activities
- Review and approve IQ/OQ/PQ protocols, reports, and change controls
- Maintain Design History Files (DHF) and support PLM activities
- Partner with production teams on GMP compliance and process improvements
Qualifications:
- 5+ years of Quality/QA Engineering experience in medical devices
- Strong knowledge of ISO 13485, 21 CFR 820, and risk management principles
- Experience with CAPA, audits, supplier quality, and validation activities
- Electromechanical, PCB (printed circuit board), and/or sensor experience highly preferred
- Familiarity with PLM systems and quality tools/methodologies
- Bachelor’s degree in Engineering, Life Sciences, or related field
