Client: Medical Device

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Project Details 12-Month contract. (Conversion likely). On-site, 5 days per week.

Responsibilities Provide expert QA guidance across design controls, specifications, test methods, usability, and risk management throughout product development. Lead product quality input in design reviews and maintain compliance documentation (DHF/DMR) per regulatory and SOP requirements. Drive risk management and human factors activities to ensure safe, user-friendly orthopedic device designs. Apply statistical and quality engineering tools for verification/validation planning, CAPA investigations, and continuous improvement initiatives. Support audits, regulatory submissions, and quality system processes related to design, risk, complaints, and CAPA.

Qualifications Bachelor’s degree with 7+ years (or 15+ years without a degree). The ideal candidate should have hands-on experience in risk identification, design verification, and testing. ASQ Certified Quality Engineer. (Preferred).