QA Compliance Specialist # JN -062021-66262

Los Angeles, California
Industry: QA Testers
Job Number: JN -062021-66262

Title       : QA Compliance Specialist

Location : Los Angeles, CA

Contract : 6 Months

 

Description:

  • 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.

 


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