Quality Engineer I

Tecomet, Inc•Claypool, IN

About The Position

The Quality Engineer I works with team members to ensure compliance with internal and external customer requirements, with a focus on quality engineering. The role supports Tecomet’s principles of continuous improvement, customer-driven innovation, and a win-first culture while meeting company financial and other performance metrics. The position maintains applicable quality system, environmental, and FDA requirements and certifications; supports manufacturing and operations in resolving quality, cost, and schedule issues; and participates in audits and inspections. It also supports the MRB and RMA processes, investigates customer complaints and related CAPA, deviations, and responses, and prepares FMEAs, control plans, quality plans, and PPAP documentation. The Quality Engineer I coordinates process validations, works to reduce dependence on inspection, facilitates operator-owned quality, and generates quality metric reports, including cost-of-quality reporting. The role requires working knowledge of manufacturing operations, FDA and ISO regulations, GMP and GDP requirements, standard problem-solving techniques, and statistical and Six Sigma concepts. Special projects may be assigned by quality management. The position may require travel up to 10%.

Requirements

Bachelor’s degree in engineering or a related field, or at least four years of experience in the medical device industry and ASQ CQE or CMQ/QE certification.
Working knowledge of standard manufacturing operations, FDA and ISO regulations, Good Manufacturing Practices (GMP), and Good Documentation Practices (GDP).
Knowledge of manufacturing operations such as forging and/or machining.
Knowledge of measuring devices, quality systems, FDA/GMP/ISO regulations, blueprint reading, GD&T, metrology, problem solving and 8D, algebra and trigonometry, Microsoft Office (Word, Excel, Outlook, PowerPoint), and Minitab.
Ability to apply statistical and Six Sigma concepts and techniques.
Ability to meet the physical requirements, which may include frequent walking, hand and arm use, talking or hearing; sitting, climbing or balancing, stooping, kneeling, crouching or crawling; and occasional lifting or moving of up to 50 pounds.
Travel up to 10%.

Nice To Haves

ASQ CQE or CMQ/QE certification.
Two years of experience in quality within the medical device manufacturing industry.
Experience with ISO 13485, FDA 820, and customer interaction.

Responsibilities

Maintain applicable quality system, environmental, and FDA requirements and certifications.
Facilitate the operator-owned quality program.
Support the MRB and RMA processes.
Work with team members and support manufacturing and operations to resolve quality, cost, and schedule issues.
Prepare FMEAs, control plans, quality plans, and PPAP documentation.
Coordinate process validations and reduce dependence on inspection.
Generate applicable quality metric reports, including cost-of-quality reports, using management by facts.
Investigate customer complaints and manage associated actions, including CAPA, deviations, and complaint responses.
Complete special projects as assigned by quality management.
Participate in audits and inspections.
Work with internal and external customers.