What are the responsibilities and job description for the Post Market Quality Engineer position at Novozen Healthcare LLC?
Title: Post Market Quality Engineer
Location: Minneapolis, MN (Onsite)
Duration: 6 Months
Job Summary
We are seeking a Post Market Quality Engineer with 3–6 years of medical device experience to support returned product complaint investigations and post-market quality activities. The ideal candidate will have expertise in product failure analysis, complaint handling, CAPA, and regulatory compliance.
Key Responsibilities
- Investigate returned medical devices and customer complaints.
- Perform product failure analysis and root cause investigations.
- Support complaint handling, CAPA, and post-market surveillance activities.
- Collaborate with cross-functional teams to resolve quality issues.
- Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and internal QMS.
Required Qualifications
- Bachelor's degree in Engineering or a related field.
- 3–6 years of Quality Engineering experience in the medical device industry.
- Hands-on experience with returned product complaint investigations.
- Strong knowledge of FDA 21 CFR Part 820, ISO 13485, CAPA, Root Cause Analysis, and Complaint Handling.
- Excellent analytical, documentation, and communication skills.