Quality Systems Engineer II – Medical Devices

Tecomet, Inc; Wilmington (MA); On-site; USD 75,000 - 110,000; Full time

Job summary

Tecomet, Inc. is seeking a Quality Engineer II to ensure compliance with internal and external customer requirements under Tecomet’s continuous improvement and customer-driven innovation framework.

You will work across teams to address quality, cost, and schedule issues and prepare essential quality documentation. The role requires a engineering degree or equivalent experience in medical devices, with knowledge of FDA/ISO regulations and GMP/GDP practices.

Qualifications

• Bachelor's degree in engineering or related field or 6+ years in medical devices.
• ASQ CQE or CMQ/QE certification preferred.
• ISO 13485, FDA 820 experience and customer interaction experience preferred.

Responsibilities

• Maintain quality system, environmental, and FDA requirements/certifications.
• Facilitate operator owned quality program.
• Support MRB and RMA processes.
• Solve quality, cost and schedule issues with manufacturing/operations.
• Prepare FMEAs, control plans, quality plans, PPAPs.
• Coordinate process validations and reduce inspection reliance.
• Generate quality metric reports (cost of quality, facts-based).
• Investigate customer complaints including CAPA and deviations.

Skills

Quality engineering experience

FDA/ISO regulatory knowledge

Medical device industry experience

Customer interaction experience

Education

Bachelor’s Degree in Engineering or related field

ASQ CQE or CMQ/QE certification

Job description

Tecomet, Inc. is seeking a Quality Engineer II to ensure compliance with internal and external customer requirements under Tecomet’s continuous improvement and customer-driven innovation framework.

You will work across teams to address quality, cost, and schedule issues and prepare essential quality documentation. The role requires a engineering degree or equivalent experience in medical devices, with knowledge of FDA/ISO regulations and GMP/GDP practices.