Manager, QA External Manufacturing

Manager, QA External Manufacturing is responsible for managing the onboarding manufacturers of sourced finished medical device products to ensure products meet current Good Manufacturing Practices, applicable medical device regulatory requirements, and for supporting business development initiatives.

Requirements

• Bachelor’s degree in a science-related discipline
• Minimum of 8+ years of directly related Quality Assurance experience in the medical device industry
• Knowledge of and experience performing supplier quality audits and involvement in external QMS certification/surveillance audits
• Knowledge of regulators including but not limited to 21CFR820, ISO 13485, ISO 9001, MDSAP, EUMDR, and applicable regulations
• Demonstrated ability to work cross-functionally
• Demonstrated ability to lead programs/projects
• Excellent team player
• Global understanding of product domains and key technology/therapeutic area/R&D disciplines
• Strong interpersonal skills, including the ability to work across cultures and personality types
• High business acumen: ability to learn quickly and adapt to new circumstances; comfort and ability to effectively order the unknown
• Excellent communication skills, both verbal and written; ability to quickly distil complex information into actions/recommendations
• Excellent understanding of the typical functional roles and responsibilities of Quality Assurance
• Practical understanding of global regulatory/quality standards and requirements

Benefits

• Competitive salaries
• Annual bonus
• 401(k) with company match
• Comprehensive medical, dental, vision coverage
• 24/7 Employee Assistance Program
• Free live and on-demand Wellbeing Programs
• Generous Paid Vacation and Sick Time
• Paid Parental Leave and Adoption Assistance
• 12 Paid Holidays
• On-Site Child Daycare
• Café
• Fitness Center