Quality Manager Medical Devices
Overview
You own quality and regulatory compliance for a growing medical technology startup, ensuring products meet FDA 21 CFR Part 820 and international standards. You will lead the QMS, manage supplier quality, and drive continuous improvement across the product lifecycle. Collaborating with a team of eight in St. Paul, you'll shape processes from design to post-market surveillance. This role offers direct impact in a startup environment and the chance to build quality systems from the ground up.
What You'll Do10
- 1Serve as the company's Quality Management Representative and primary contact for quality issues.
- 2Collect, analyze, and report quality KPIs, leading management review meetings for data-driven decisions.
- 3Maintain QMS compliance with FDA 21 CFR Part 820 and other medical technology regulations.
- 4Develop and update quality procedures, work instructions, and documentation for operations and suppliers.
- 5Plan and conduct internal audits, verifying QMS effectiveness and identifying improvements.
- 6Support external audits, including supplier and customer audits, with timely corrective actions.
- 7Lead risk management activities: hazard analyses, design and process risk assessments, and mitigation controls.
- 8Monitor manufacturing processes to ensure product quality and compliance with design specs and regulations.
- 9Drive RCA and CAPA investigations for nonconformances, deviations, and customer complaints.
- 10Review and approve process validations (IQ, OQ, PQ) and batch records for product release.
Requirements10
- 15-7 years in quality engineering or assurance within medical or regulated manufacturing.
- 2Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, Industrial) or related technical field.
- 3Hands-on expertise with FDA 21 CFR Part 820 (Quality System Regulation).
- 4Experience with risk management standards, including hazard analyses and risk assessments.
- 5Proficiency in quality tools: RCA, CAPA, FMEA, Control Plans, SPC, Gauge R&R, DOE.
- 6Supplier qualification, auditing, and ongoing management in a regulated environment.
- 7Strong analytical and problem-solving skills for complex quality challenges.
- 8Excellent communication skills for internal and external stakeholders.
- 9Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
- 10Experience with ERP systems and eQMS software (preferred).
Salary Insight
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