Essential Duties & Responsibilities
- Ensure compliance with FDA, ISO, and environmental quality standards.
- Drive operator-owned quality initiatives and support MRB/RMA processes.
- Collaborate with manufacturing to resolve quality, cost, and schedule issues.
- Develop FMEAs, control plans, PPAPs, and quality plans.
- Lead process validations and reduce reliance on inspections.
- Generate quality metrics (Cost of Quality, CAPA, etc.) and reports.
- Investigate customer complaints and manage CAPAs and deviations.
- Write and maintain quality procedures and work instructions.
- Participate in audits, inspections, and special projects.
- Apply statistical methods, Six Sigma, and standard problem-solving tools.
Knowledge & Skills
- Experience with forging/machining and quality systems.
- Proficient in FDA, GMP, ISO regulations, and ISO 13485.
- Strong in blueprint reading, GD&T, metrology, 8D problem-solving.
- Skilled in Microsoft Office and Minitab.
- Familiarity with measuring devices and statistical analysis.
Education & Experience
- Bachelor's in Engineering or related field, or 6+ years in medical device industry with ASQ certification (CQE/CMQ-OE preferred).
- 2+ years in quality roles within medical device manufacturing preferred.
Work Environment & Physical Demands
- Office and production floor setting with PPE requirements.
- Exposure to noise, moving machinery, and airborne particles.
- Ability to perform repetitive tasks, stand/walk for extended periods, and meet vision and dexterity standards.