QA Compliance Specialist

Role: QA Compliance Specialist

Location:

2900 Easton Square Place, Columbus, OH 43219
Duration: 11 months

Shift: 08: 30 AM 05: 00 PM
Description:
The QA Compliance Specialist position exists to support the execution of quality & regulatory functions in the organization to ensure compliance with 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 client s 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.

Lance Soft