Quality Engineer

At Amphenol Alden, we're dedicated to providing critical support to patients globally. Every device we manufacture directly impacts someone's loved one, a responsibility we hold with utmost seriousness. With roots as a family business over 80 years ago, we maintain a dynamic, entrepreneurial spirit, even now as part of a global corporation. We recognize that our employees are at the cornerstone of our future, and we prioritize exceptional benefits, competitive compensation, work/life balance, and career development. Due to our continuous expansion, we're seeking talented individuals to strengthen our team. We currently have an exciting opportunity for a 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.