Quality Engineer I — Med Device (FDA/ISO/GMP)

Tecomet, Inc; Warsaw (IN); On-site; USD 65,000 - 85,000; Full time

Job summary

Tecomet, Inc. is seeking a Quality Engineer I to help ensure adherence to quality systems and customer requirements. The role focuses on continuous improvement within a medical device manufacturing context, aligning with GMP/GDP practices and regulatory standards.

You will support MRB/ RMA processes, prepare FMEA/PPAP documents, and assist in process validations while working with cross-functional teams to resolve quality, cost, and schedule issues.

Qualifications

• Bachelor's degree in Engineering or related field; or 4+ years in medical device QA with ASQ CQE/CMQ/QE.
• ASQ CQE or CMQ/QE preferred; 2+ years in quality within medical device manufacturing desirable.
• ISO 13485, FDA 820 knowledge and customer interaction experience preferred.

Responsibilities

• Maintain applicable quality system, environmental, and FDA requirements/certifications.
• Facilitate operator owned quality program.
• Support MRB and RMA processes.
• Work with manufacturing to solve quality, cost and schedule issues.
• Prepare FMEA's, control plans, quality plans, PPAP.
• Coordinate process validations and reduce dependence on inspection.
• Generate quality metric reports: cost of quality, management by fact.
• Investigate customer complaints including CAPA, deviations, and responses.
• Participate in audits and inspections.

Skills

Measuring devices understanding

Statistical analysis

Problem solving (8D)

Regulatory knowledge

Education

Bachelor's degree in Engineering or related field

ASQ CQE or CMQ/QE certification (preferred)

Tools

Minitab

Job description

Tecomet, Inc. is seeking a Quality Engineer I to help ensure adherence to quality systems and customer requirements. The role focuses on continuous improvement within a medical device manufacturing context, aligning with GMP/GDP practices and regulatory standards.

You will support MRB/ RMA processes, prepare FMEA/PPAP documents, and assist in process validations while working with cross-functional teams to resolve quality, cost, and schedule issues.