Quality Inspector – Medical Devices, (St. Louis, Missouri).
Our client, a leader in manufacturing high-quality components and assemblies for medical devices and healthcare applications, seeks a Quality Inspector to support quality and training documentation. This role demands technical and quality expertise within an FDA-regulated, ISO 13485 environment and emphasizes operational excellence and regulatory compliance.

Position is a Direct Hire. Working collaboratively with Operations, Manufacturing, and Engineering teams, the Quality Inspector focus on supporting the transfer of manufacturing processes, quality documentation, and ensuring alignment with FDA and ISO standards.  

Key Responsibilities:
Ensure all quality inspection activities follow FDA QSR (21 CFR 820), ISO 13485, and relevant global medical device standards.
Review, update, and verify device history records, work instructions, validation protocols, and training certification documents for the new site.
Collaborate with R&D, Operations, Manufacturing, Regulatory, and Quality Assurance teams to facilitate the successful transfer of quality systems and training materials.
Participate in Design & Site Transfer (DSR) activities and support effective onsite training initiatives.
Update and maintain training documentation and assist with internal audits during the transition period.
Maintain meticulous records and use strong technical writing skills while managing risk throughout the process.
Assist with the review and approval of engineering change orders, nonconformances, and CAPAs as required.

Qualifications:
Minimum 3 years of quality assurance or quality inspection experience in the medical device, diagnostic, or biotechnology industry, with proven FDA familiarity.
Strong knowledge of FDA QSR (21 CFR 820), ISO 13485, quality documentation, design controls, validation, and CAPA processes.
Strong hands on inspection skills.
Skilled in data analysis, risk management, deviation handling, technical writing, and audit support.
Excellent communication and teamwork skills; consistent attention to detail.
Commitment to operational and regulatory priorities over titles or manufacturing-only background.
Comfortable working in large cross-functional teams; leadership of the transfer process is not expected.

More About Our Client:
Specializing in the design, prototyping, and manufacture of highly engineered components and assemblies for medical devices, the client provides life-saving products for cardiology, neurology, gastroenterology, orthopedics, and surgery. Expertise includes endoscopy, electrosurgery, vascular access, and other targeted interventional procedures requiring precision and regulatory compliance. Operations feature advanced techniques like precision braiding, extrusion, laser processing, thermal forming, injection molding, and scalable assembly; rapid prototyping and engineering support are core strengths.
Joining this team offers a unique opportunity to participate in cutting-edge manufacturing transitions and help drive innovation in the medical device industry.

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