Quality Engineer I - Medical Device Process Improvement

Tecomet; Claypool (IN); On-site; USD 60,000 - 86,000; Full time

Benefits offered by this job

Medical Insurance

401(k) Plan

Job summary

Tecomet seeks a Quality Engineer I to ensure compliance with internal and external customer requirements, focusing on quality engineering within our continuous improvement culture. You will partner with team members to uphold GMP, GDP, and ISO standards while driving quality performance.

Responsibilities include maintaining quality systems, supporting MRB/RMA, and preparing FMEAs, control plans, and PPAPs. You will work with manufacturing to solve quality and schedule issues and participate in

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 applicable quality systems and ensure FDA/ISO compliance.
• Facilitate operator owned quality program.
• Support MRB and RMA processes.
• Work with manufacturing/operations to solve quality, cost and schedule issues.
• Prepare FMEAs, control plans, quality plans, PPAPs.
• Coordinate process validations and reduce reliance on inspection.
• Generate quality metric reports (cost of quality, mgmt by facts).
• Investigate customer complaints including CAPA, deviations and responses.
• Participate in audits and inspections.

Skills

Quality systems

Problem solving

8D problem solving

Manufacturing operations

Auditing

Statistical analysis

Communication

Education

Bachelor’s Degree in Engineering

ASQ CQE or CMQ/QE

Tools

Minitab

MS Office

Job description

Tecomet seeks a Quality Engineer I to ensure compliance with internal and external customer requirements, focusing on quality engineering within our continuous improvement culture. You will partner with team members to uphold GMP, GDP, and ISO standards while driving quality performance.

Responsibilities include maintaining quality systems, supporting MRB/RMA, and preparing FMEAs, control plans, and PPAPs. You will work with manufacturing to solve quality and schedule issues and participate in