Quality Engineer at our new Stoughton MA facility.

Job Summary: The medical device quality engineer supports the development, manufacture, and ongoing compliance of medical devices with a regulated quality management system. This role is responsible for ensuring products and processes meet applicable regulatory requirements, internal quality standards, and customer expectations.

Primary Duties and Responsibilities:
• Work with engineering to develop inspection planning and documentation packages for customers.
• Work with customers regarding nonconformance, quality alerts and CAPA (problem solve).
• Execute First Article Inspections (FAI), CPK Studies, and GR&R

Skills/Qualifications Needed:
• Experience as a Quality Engineer in a manufacturing environment.
• Knowledge of ISO1348:16 and 21 CFR Part 820 Medical Device Requirements.
• Knowledge of PFMEA, Process Control Plans, Process Maps, other Engineering and Quality related processes.
• Knowledge of Validation (IQ, OQ, PQ)
• Computer skills: Word, Excel, PowerPoint, Minitab, etc.
• 4-Year College Degree; preferably in engineering or related.
• Ability to travel globally as needed to other AAP, supplier, and customer locations.
• Minimum 8-12 years' related experience in a manufacturing environment.
• Ability to travel as needed to other AAP, supplier, and customer locations.

Desired Skills:
• Lead auditor training to ISO13485:16 or ISO9001:15.
• Highly organized with excellent verbal and written skills, self-motivated.
• Understanding of REACH, ROHS, and Conflict Materials.

What We Offer:
• An opportunity to join a growing team dedicated to making a difference.
• Competitive salary, bonuses, and comprehensive benefits program, including medical, dental, vision, short and long-term disability, 401(K), PTO, HSA, FSA, employee discounts, life insurance, and employee activities.