Quality Engineer Amphenol Alden Products Company - 3.5 Stoughton, MA Job Details Full-time $75,000 - $85,000 a year 2 hours ago Benefits Health savings account Disability insurance Health insurance Dental insurance 401(k) Flexible spending account Paid time off Vision insurance Employee discount Life insurance Qualifications Quality control statistical data analysis Regulatory compliance Minitab Manufacturing facility experience Process mapping Process modeling Production validation processes Medical device manufacturing facility experience Biomedical regulatory compliance Productivity software FDA regulations Statistical analysis tools Business process modeling Full Job Description Join Amphenol Alden and Make a Differenc e 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 Applicant Tracking Software by

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