• 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 associated actions 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.
• Writing and maintaining quality related work instructions and procedures.

KNOWLEDGE and SKILLS:

• Manufacturing operations – forging and/or machining.
• Measuring devices, Quality Systems.
• Regulations – FDA, GMP and ISO.
• Blueprint reading; GD&T, Metrology.
• Problem solving and 8D.
• Math skills (algebra, trigonometry) skills.
• Microsoft office (Word, Excel, Outlook, PowerPoint).
• Minitab.

EDUCATION and EXPERIENCE:

• Bachelor's Degree in Engineering or related field.
• OR without a degree, a minimum of 6 years’ experience within the Medical Device Industry, and Certification (ASQ CQE or CMQ/OE).
• 2 years’ experience in quality within medical device manufacturing industry preferred.
• ISO 13485, FDA 820 and customer interaction experience preferred