Senior Quality Engineer

Salary :

$115,000 - 130,000 yearly

Company : Enterra Medical

Job Type : Full Time

St. Louis Park, Mn

Number of Applicants

000+

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Job Description - Senior Quality Engineer

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:

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

Required Qualifications:

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

Preferred Qualifications:

Experience with sterilization, electrotechnical trouble shooting and medical devices software
Prior involvement in FDA inspections, Notified Body audits, or international regulatory submissions.

Total Compensation: $115,000-130,000 DOE

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Senior Quality Engineer

Job Description - Senior Quality Engineer

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