- 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