Quality Engineer I: Medical Device QA & Process Improvement

Tecomet, Inc; Claypool (IN); On-site; USD 52,000 - 75,000; Full time

Job summary

Tecomet, Inc. in Indiana is seeking a Quality Engineer I to ensure compliance with FDA, ISO, and GMP requirements. You will work with manufacturing to drive quality improvements and support CAPA, MRB, and process validations.

Responsibilities include maintaining quality systems, preparing FMEA and control plans, collecting quality metrics, and leading problem-solving activities. Bachelor’s degree or equivalent experience preferred.

Qualifications

• Bachelor’s Degree in Engineer or related field, or 4 years’ experience in medical device industry with certification.
• 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

• Maintaining applicable quality system, environmental, and FDA requirements/certifications.
• Facilitate operator owned quality program.
• Supporting the MRB and RMA processes.
• Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.
• Prepare FMEA’s, controls plans, quality plans, PPAP.
• Coordinate process validations and reduce dependence on inspection.
• Generating applicable quality metric reports; cost of quality, management by facts.
• Investigate customer complaints including CAPA, deviations, and complaint responses.
• Special projects as assigned by quality management.
• Must demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations.
• Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements.
• Standard problem-solving techniques.
• Applies statistical and Six Sigma concepts and techniques.
• Works with Internal and External Customers.
• Participates in audits and inspections.

Skills

Manufacturing operations - forging and

Measuring devices

Quality Systems

Regulations - FDA, GMP and ISO

Blueprint reading

GD&T

Metrology

Problem solving and 8D

Math skills

Microsoft Office

Minitab

Education

Bachelor’s Degree in Engineer or related field

ASQ CQE or CMQ/QE certification

Job description

Tecomet, Inc. in Indiana is seeking a Quality Engineer I to ensure compliance with FDA, ISO, and GMP requirements. You will work with manufacturing to drive quality improvements and support CAPA, MRB, and process validations.

Responsibilities include maintaining quality systems, preparing FMEA and control plans, collecting quality metrics, and leading problem-solving activities. Bachelor’s degree or equivalent experience preferred.