Quality Engineer I: Medical Device Quality & Compliance

tecometunitedstates; Warsaw (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

Tecomet is seeking a Quality Engineer I to ensure compliance with quality systems, FDA and ISO requirements, and customer specifications. You will support MRB/RMA, CAPA, FMEA, control plans and PPAPs while collaborating with manufacturing and operations to solve complex quality, cost, and schedule challenges.

The role requires a Bachelor’s degree in engineering or equivalent experience in medical devices, with ASQ CQE/CMQ/QE preferred.

Qualifications

• Bachelor’s Degree in Engineer or related field, or minimum of 4 years in medical device industry with certification (ASQ CQE or CMQ/QE).
• ASQ CQE or CMQ/QE preferred.
• 2 years’ experience in quality within medical device manufacturing preferred.
• ISO 13485, FDA 820 and customer interaction experience preferred.

Responsibilities

• Maintain applicable quality systems, 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, and PPAPs.
• Coordinate process validations and reduce dependence on inspection.
• Generate quality metrics and CAPA, deviations, and complaint responses.
• Participate in audits and inspections.

Skills

Quality systems

GMP

GD&T

Minitab

8D problem solving

Metrology

Blueprint reading

Statistical methods

MS Excel

Education

Bachelor's degree in Engineering

ASQ CQE or CMQ/QE (preferred)

Tools

Minitab

MS Office

Job description

Tecomet is seeking a Quality Engineer I to ensure compliance with quality systems, FDA and ISO requirements, and customer specifications. You will support MRB/RMA, CAPA, FMEA, control plans and PPAPs while collaborating with manufacturing and operations to solve complex quality, cost, and schedule challenges.

The role requires a Bachelor’s degree in engineering or equivalent experience in medical devices, with ASQ CQE/CMQ/QE preferred.