Senior Quality Engineer
St. Louis Park, MN
Full Time
Mid Level
Senior Quality Engineer
Location: St. Louis Park, MN
Job Summary:
We are seeking a Senior Quality Engineer to join our team to focus on Class III medical devices (e.g. implantable, life-sustaining, or high-risk active implantable devices). This role will emphasize regulatory rigor (FDA PMA pathway, heightened scrutiny), and design/sustain engineering for high-risk products.
Responsibilities:
Location: St. Louis Park, MN
Job Summary:
We are seeking a Senior Quality Engineer to join our team to focus on Class III medical devices (e.g. implantable, life-sustaining, or high-risk active implantable devices). This role will emphasize regulatory rigor (FDA PMA pathway, heightened scrutiny), and design/sustain engineering for high-risk products.
Responsibilities:
- Provide expert quality leadership for Class III medical devices throughout the product lifecycle—from design and development through commercialization with a focus on quality system regulation adherence and management.
- Play a critical role in ensuring patient safety, regulatory compliance, and product reliability for high-risk, life-sustaining or implantable technologies.
- Serve as the quality lead for post-market and sustaining quality initiatives such as evaluating change impacts, managing dispositions, and driving improvement projects.
- Drive compliance to FDA’s quality management system regulation (21 CFR 820) and ISO 13485
- Plan and support internal, and outside agency audits
- Support returned product / complaint measuring and monitoring
- Own or significantly contribute to design control, equipment management, and supplier/document control management
- Lead root cause investigations, nonconformance (NCR) dispositions, and CAPA processes thorough science-based investigations and effective, verifiable corrective/preventive actions and measurable effectiveness
- Support supplier quality activities including supplier qualification, auditing, incoming inspection strategy, and SCAR resolution for critical components and contract manufacturers
- Monitor and trend key quality metrics (e.g., CAPA effectiveness, scrap rates) and present during management reviews
- Additional duties as assigned
- Bachelor's degree in engineering (Mechanical, Biomedical, Electrical, Chemical, or related), Life Sciences, or equivalent technical discipline.
- Expertise in FDA PMA requirements, ISO 13485, risk management (ISO 14971) and design controls in a highly regulated environment.
- Minimum of 2 years' experience directly supporting Class III devices (implantable, active implantable, cardiovascular, neuromodulation, or similar high-risk technologies.
- 5+ years of progressive Quality Engineer experience in the medical device industry.
- Strong working knowledge of FDA Quality Management System Regulation (21 CFR Part 820), ISO 13485, ISO 14971, and EU MDR requirements for Class III devices
- Experience with sterilization, electrotechnical trouble shooting and medical devices software
- Prior involvement in FDA inspections, Notified Body audits, or international regulatory submissions.
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