Quality Inspector

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 in an FDA-regulated, ISO 13485 environment.

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.

About the Company

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.

Benefits

• Voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, and a legal plan.
• Retirement savings plan.
• Service bonus and holiday pay plans (earn up to eight paid holidays per benefit year).
• Transit spending account.
• Paid sick leave under the applicable state or local plan.