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.