QA Compliance Specialist

The QA Compliance Specialist position exists to support the execution of quality & regulatory functions in the organization to ensure compliance of the AV-SH quality/business systems to applicable regulations, standards and corporate policies. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. 1. Support external audit activities (FDA, FDB, ISO registrar audits etc.). 2. Audit areas of *** Vascular Quality System. 3. Support administration of Quality System processes (CAPAs, Internal Audits etc.). 4. Generate and distribute periodic open CAPA and Internal Audit Corrective Action (IACA) reports. 5. Track and trend compliance activities on a periodic basis. This may include CAPA & IACA metrics etc. Generate compliance metrics for Management Reviews. 6. Assist the organization to receive timely feedback on open corrective actions. 7. Participate in cross divisional activities to integrate quality system information. 8. Conduct review and update Quality System procedures as necessary. 9. Assist in developing & conducting Quality System training as necessary. 10. File Quality Records (audit reports, IACAs, CAPAs etc.). 11. Ensure that all responsibilities are carried out in compliance with governing regulations and standards. Other duties as assigned. Bachelor Degree or equivalent plus 4 years of related work experience or equivalent combination.