Engineer

📋 Description Assess compliance with applicable regulations through supplier oversight activities Interpret and apply governmental regulations, guidelines, policies, and procedures Manage the Quality Agreement life cycle; lead creation, periodic review, and termination Serve as an expert in GxP requirements within R&D Collaborate with R&D functional areas to resolve external supplier quality issues Prioritize activities to ensure study/program objectives are met 🎯 Requirements Bachelor’s Degree preferably in technical area such as Chemistry, Pharmacy, Biology, Microbiology Thorough understanding of international regulatory standards (GxP) Understanding of Medical Device regulations and standards (e.g., ISO 13485, 21 CFR Part 820) Must have technical background and thorough understanding of supplier oversight Must understand quality/operational systems supporting study/product design, device development Excellent verbal and written communication skills 🎁 Benefits Paid time off (vacation, holidays, sick) Medical/dental/vision insurance 401(k) Long-term incentive programs