Bachelor's degree in Quality Engineering, Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline. We are urgently seeking a Senior Quality Engineer with strong hands-on experience in FDA-regulated medical device manufacturing.
Numbers & Facts
Location
Brooklyn Park, MN
Description
We are urgently seeking a Senior Quality Engineer with strong hands-on experience in FDA-regulated medical device manufacturing.
10+ years of Quality Engineering experience in medical device manufacturing.
Strong experience with FDA-regulated environments & Quality Systems.
Validation experience: IQ/OQ/PQ, TMV & Process Validation.
FDA-compliant quality documentation.
PFMEA, Control Plans, Nonconformance & CAPA.
Strong knowledge of ISO 13485, FDA 21 CFR Part 820 & Risk Management.
Customer complaint investigations & Root Cause Analysis.
Manufacturing readiness, NPI & scale-up.
Strong technical writing and documentation skills.
Internal/external audit support preferred.
Injection molding, assembly or contract manufacturing experience is a plus
Bachelor's degree in Quality Engineering, Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline.
Lead and support Quality Engineering activities within FDA-regulated medical device manufacturing.
Manage Technology, Product, Process, and Manufacturing Transfers.
Develop and execute IQ/OQ/PQ, Test Method Validation (TMV), and Process Validation activities.
Prepare and maintain FDA-compliant quality and validation documentation.
Develop and maintain PFMEA, Control Plans, Risk Assessments, and quality plans.
Investigate nonconformances, CAPA, customer complaints, and quality issues.
Perform root cause analysis and implement effective corrective and preventive actions.
Support New Product Introduction (NPI), manufacturing readiness, scale-up, and process improvements.
Ensure compliance with ISO 13485, FDA 21 CFR Part 820, GMP, and applicable risk management requirements.
Support internal and external quality audits and regulatory inspections.
Collaborate with Manufacturing, R&D, Operations, Regulatory, Suppliers, and cross-functional teams.
Provide technical writing, quality documentation, and engineering support.
Support manufacturing processes such as injection molding, assembly, and contract manufacturing, when applicable.