Quality Engineer

Amphenol-Alden-Products-Company; Stoughton (MA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Bonus program

Medical benefits

Dental benefits

Vision benefits

401K

PTO

HSA

FSA

Life insurance

Employee discounts

Job summary

Amphenol Alden Products is seeking a Medical Device Quality Engineer in Massachusetts to support development, manufacture, and ongoing compliance under a regulated quality system.

You will collaborate with engineering on inspection planning, handle nonconformances and CAPA, and perform FAI, CPK studies, and GR&R to ensure regulatory and customer expectations are met.

Qualifications

• Experience as a Quality Engineer in a manufacturing environment.
• Knowledge of ISO13485:2016 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.

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

Quality Engineer

ISO13485:2016

FDA 21 CFR Part 820

PFMEA

Process Control Plans

Process Maps

IQ/OQ/PQ Validation

MS Office

Minitab

Travel flexibility

Experience 8–12 years

Education

Bachelor's degree in Engineering

Tools

MS Office

Minitab

Job description

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