Quality Engineer, Medical Devices — Compliance & QA

Merrimack Manufacturing; Manchester (NH); On-site; USD 65,000 - 90,000; Full time

Job summary

Merrimack Manufacturing in Manchester, NH seeks a Quality Engineer to support manufacturing quality operations in a fast-paced medical device environment, including design verification, inspection, and production testing.

You will drive PFMEAs, control plans, sampling methods, and CAPAs, participate in ISO 13485 audits, and work with customers to resolve nonconformances using Six Sigma tools and data analysis.

Qualifications

• 3+ years in Quality Control for medical devices.
• Experience with 21 CFR 820 and ISO 13485:2016.
• Experience participating in internal and external audits.

Responsibilities

• Support manufacturing quality operations in a fast-paced medical device environment.
• Transition products from development to manufacturing per standards (21 CFR 820, ISO 13485).
• Develop and approve PFMEAs and control plans.
• Develop inspection processes and sampling plans by risk level.
• Contribute to Device Master Records and Device History Records.
• Lead root-cause investigations and CAPA using data analysis.

Skills

Quality control

Regulatory compliance

Audits

Education

Bachelor’s degree or equivalent (Industrial/Mechanical/Life sciences)

Tools

Six Sigma

Job description

Merrimack Manufacturing in Manchester, NH seeks a Quality Engineer to support manufacturing quality operations in a fast-paced medical device environment, including design verification, inspection, and production testing.

You will drive PFMEAs, control plans, sampling methods, and CAPAs, participate in ISO 13485 audits, and work with customers to resolve nonconformances using Six Sigma tools and data analysis.