Join Amphenol Alden and Make a Difference in Patient Care Worldwide!
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.
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.
Amphenol Alden Products is an Equal Opportunity Employer