- - Quality
- Brockton, MA, USA
- Full Time
Join us to help save lives: consider a career at Amphenol Alden Products!
At Amphenol Alden we play a part in providing excellent care to patients the world over. We know that every device we support provides care to someone's family member and this is a responsibility we take seriously. Family is core to who we are at Amphenol Alden. Over 80 years ago we started as a family business and we continue to maintain an atmosphere that is dynamic and entrepreneurial. Now, as part of a global corporation, we remain committed to the culture that got us here.
Because our employees are an investment in our future, we know the importance of providing exceptional benefits, competitive compensation, and career development. As part of Amphenol Corporation, career paths aren't limited to the hierarchy of our local sites; when needs arise at any of our sister companies we look internally to our top performers for opportunities for advancement.
Due to our continuing growth, Amphenol Alden has a need for talented individuals to strengthen our team. We currently have an exciting opportunity available for Quality Engineer at our Brockton, MA location.
Job Summary: Provide support to the overall Amphenol Alden quality organization dealing with customer requirements, change notification, CAPA, and MRB.
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
• 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 (post COVID) as needed to other AAP, supplier, and customer locations.
• Minimum 5 years' related experience in a manufacturing environment.
• 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!
Competitive salary and generous benefits program which includes medical, dental, short and long-term disability, 401(K), hospital indemnity, HSA, FSA, employee discounts, employee activities and more!
Amphenol Alden Products is an Equal Opportunity Employer
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