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