Quality Engineer I – Medical Devices, Compliance & CAPA

Tecomet; Warsaw (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

Tecomet in Warsaw, IN seeks a Quality Engineer I to ensure compliance with FDA/ISO regulations and support continuous improvement. You will work with manufacturing to resolve quality, cost, and schedule issues and prepare quality deliverables.

Responsibilities include FMEA, control plans, PPAP, process validations, CAPA, MRB, and quality metrics reporting. Experience with 8D, GD&T, metrology, and MS Office/Minitab is valued.

Qualifications

• Bachelor's degree in Engineering or related field; or 4+ years in medical device industry with certification.
• ASQ CQE or CMQ/QE preferred.

Responsibilities

• Maintain quality system and ensure FDA/ISO compliance.
• Facilitate operator-owned quality program.
• Support MRB and RMA processes.
• Collaborate with manufacturing/operations to solve quality, cost and schedule issues.
• Prepare FMEA, control plans, quality plans, and PPAP.
• Coordinate process validations and reduce dependence on inspection.
• Generate quality metrics reports (cost of quality and data-driven decisions).
• Investigate customer complaints including CAPA, deviations, and responses.
• Participate in audits and inspections.
• Apply Six Sigma tools and problem-solving approaches.

Skills

Quality systems

FDA/ISO regulations

GD&T

Metrology

8D problem solving

Minitab

Microsoft Office

Education

Bachelor's Degree in Engineering

ASQ CQE or CMQ/QE

Tools

Minitab

Microsoft Office

Job description

Tecomet in Warsaw, IN seeks a Quality Engineer I to ensure compliance with FDA/ISO regulations and support continuous improvement. You will work with manufacturing to resolve quality, cost, and schedule issues and prepare quality deliverables.

Responsibilities include FMEA, control plans, PPAP, process validations, CAPA, MRB, and quality metrics reporting. Experience with 8D, GD&T, metrology, and MS Office/Minitab is valued.