Senior Quality Engineer, Medical Devices: CAPA & FAI Lead

Amphenol Alden; Stoughton (MA); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) plan

PTO, HSA, FSA, life insurance

Job summary

Amphenol Alden is seeking a medical device quality engineer to support development, manufacture, and ongoing compliance under a regulated quality management system. This role ensures products and processes meet regulatory requirements, internal quality standards, and customer expectations.

The position involves creating inspection plans, handling nonconformance, CAPA and quality alerts, and performing FAI/CPK/GR&R analyses to verify product quality and process capability.

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.
• Ability to travel as needed to other AAP, supplier, and customer locations.

Responsibilities

• Collaborate with engineering to develop inspection planning and documentation packages for customers.
• Address nonconformances, quality alerts, and CAPA with customers.
• Execute First Article Inspections (FAI), CPK Studies, and GR&R.

Skills

Quality engineer

Documentation skills

Travel readiness

Education

Engineering degree

Tools

Minitab

MS Word

MS Excel

PowerPoint

Job description

Amphenol Alden is seeking a medical device quality engineer to support development, manufacture, and ongoing compliance under a regulated quality management system. This role ensures products and processes meet regulatory requirements, internal quality standards, and customer expectations.

The position involves creating inspection plans, handling nonconformance, CAPA and quality alerts, and performing FAI/CPK/GR&R analyses to verify product quality and process capability.