- Assures compliance to policies, procedures, and applicable world-wide regulations.
- Develops and mentors staff
- Develops KPls to best display Quality activity for the site.
- Prepares reporting on Quality KPls, support and improvement activities
- Responsible for leading facility internal and external and external audits
- Prepares Quarterly Management Review/ Monthly Operating Reviews
- Establishes annual improvement/ Quality Objectives for the site in coordination with other site leads.
Required Education / Experience:
- BS technical discipline
- 8-10+ years of QA experience in the medical device or similar industry
- Minimum of 5 years Quality management experience.