Quality Inspector

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. Client prefers a Contract to Hire (for speed to hire purposes). However, is a Direct Hire option an absolute must for you? Apply regardless, we still want to hear from you! Summary Working collaboratively with Operations, Manufacturing, and Engineering teams, the Quality Inspector focuses 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 (21CFR820), ISO13485, 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 3years of quality assurance or quality inspection experience in the medical device, diagnostic, or biotechnology industry, with proven FDA familiarity. Strong knowledge of FDA QSR (21CFR820), ISO13485, quality documentation, design controls, validation, and CAPA processes. 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 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. Benefits Medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, and legal plan. Retirement savings plan. Service bonus and holiday pay plans (up to eight paid holidays per benefit year). Transit spending account. Paid sick leave under applicable state or local plan. Equal Employment Opportunity Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E‑Verify and will provide the federal government with your Form I‑9 information to confirm that you are authorized to work in the U.S. #J-18808-Ljbffr