Quality Engineer I - Med Devices | GMP/ISO Focus

tecometunitedstates; Claypool (IN); On-site; USD 65,000 - 85,000; Full time

Job summary

Tecomet is seeking a Quality Engineer I in Indiana to support quality systems and regulatory compliance. You will work with manufacturing to address quality, cost, and schedule issues, prepare FMEA and PPAP documentation, and coordinate process validations.

The role emphasizes GMP/GDP, Six Sigma concepts, and customer-focused problem solving, with opportunity to contribute to continual improvement initiatives within a medical device environment.

Qualifications

• Bachelor’s Degree in Engineering or related field or minimum 4 years’ experience in Medical Device Industry with certification.
• ASQ CQE or CMQ/QE preferred
• 2 years’ experience in medical device quality preferred
• ISO 13485, FDA 820 and customer interaction experience preferred

Responsibilities

• Maintaining applicable quality system, environmental, and FDA requirements/certifications.
• Facilitate operator owned quality program.
• Supporting MRB and RMA processes.
• Solve quality, cost and schedule issues with manufacturing/operations.
• Prepare FMEA’s, controls plans, quality plans, PPAP.
• Coordinate process validations and reduce inspection reliance.
• Generate quality metric reports (cost of quality, facts-based management).
• Investigate customer complaints including CAPA, deviations, and responses.
• Participate in audits and inspections.

Skills

Measuring devices

Quality systems

Regulations (FDA, GMP, ISO)

Blueprint reading

GD&T

Metrology

Problem solving

8D

Math skills

MS Office

Minitab

Education

Bachelor's degree in Engineering or related field

ASQ CQE or CMQ/QE (preferred)

2 years’ experience in medical device quality (preferred)

Tools

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Job description

Tecomet is seeking a Quality Engineer I in Indiana to support quality systems and regulatory compliance. You will work with manufacturing to address quality, cost, and schedule issues, prepare FMEA and PPAP documentation, and coordinate process validations.

The role emphasizes GMP/GDP, Six Sigma concepts, and customer-focused problem solving, with opportunity to contribute to continual improvement initiatives within a medical device environment.