Quality Engineer II — Compliance & Training Lead

Coghlin Companies Inc; West Boylston (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

Cogmedix is seeking a Quality Engineer to lead compliance, training, and quality assurance for medical device manufacturing. You will drive process qualifications, control plans, and supplier quality initiatives to ensure products meet stringent standards.

The role requires ISO-13485/cGMP experience, a strong QA mindset, and a track record with CAPA, ECN/ECO processes, and RMA reviews on production lines.

Qualifications

• Bachelor’s degree in science or engineering.
• 5 years professional experience in medical subassembly and finished device manufacturing.
• Experience in ISO-13485 and cGMP environments.
• Certified Quality Engineer (CQE) preferred.

Responsibilities

• Lead compliance adherence and promote quality standards.
• Train personnel, customers and suppliers on workmanship and quality standards.
• Ensure outgoing product is manufactured in a compliant manner.
• Support process qualification/validation and new product introductions.
• Develop and execute Control Plans.
• Review device history records for quality approval.

Skills

Quality engineering

Medical device manufacturing

ISO-13485 familiarity

CQE preferred

Education

Bachelor’s degree in science or engineering

Tools

Omnify PLM

PFMEA

Control Plans

Job description

Cogmedix is seeking a Quality Engineer to lead compliance, training, and quality assurance for medical device manufacturing. You will drive process qualifications, control plans, and supplier quality initiatives to ensure products meet stringent standards.

The role requires ISO-13485/cGMP experience, a strong QA mindset, and a track record with CAPA, ECN/ECO processes, and RMA reviews on production lines.