QA Compliance Specialist # JN -062021-66262
Title : QA Compliance Specialist
Location : Los Angeles, CA
Contract : 6 Months
- 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.
- Support external audit activities (FDA, FDB, ISO registrar audits etc.).
- Audit areas of Abbott Vascular Quality System.
- Support administration of Quality System processes (CAPAs, Internal Audits etc.).
- Generate and distribute periodic open CAPA and Internal Audit Corrective Action (IACA) reports.
- Track and trend compliance activities on a periodic basis. This may include CAPA & IACA metrics etc. Generate compliance metrics for Management Reviews.
- Assist the organization to receive timely feedback on open corrective actions.
- Participate in cross divisional activities to integrate quality system information.
- Conduct review and update Quality System procedures as necessary.
- Assist in developing & conducting Quality System training as necessary.
- File Quality Records (audit reports, IACAs, CAPAs etc.).
- Ensure that all responsibilities are carried out in compliance with governing regulations and standards. Other duties as assigned.
Education: Bachelor Degree or equivalent plus 4 + years of related work experience or equivalent combination.