Job Details

Client: Medical Device

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).