QA Compliance Specialist in Saint Paul, MN at Volt

Date Posted: 9/20/2018

Job Snapshot

Job Description

Volt Workforce Solutions has partnered with a well known medical device manufacturer to hire a QA Compliance Specialist for their St. Paul location.

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 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.  
  • Bachelor Degree or equivalent plus 4 + years of related work experience or equivalent combination.

Volt is an Equal Opportunity Employer