1+ months
2018-04-062018-08-19

Clinical Quality Manager

Abbott
Santa Clara, CA

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

  • Manage quality system and manufacturing process audits to applicable standards, regulations and company procedures / policies.
    • Review audit reports that establish the outcome of the audit and detail the non-conformances identified during the audit.
      • Track audit results, including corrective actions, and provide follow-up to these actions, as required.
      • May perform Supplier Audits, as needed.
        • Participate in third party and regulatory agency inspections as a subject matter expert as needed.
          • Manage Supplier CAPAs and non-supplier CAPAs, as needed.
            • Prepare Supplier/CAPA metrics for management review meetings
              • Communicate effectively and efficiently by both written and oral modes.
                • Demonstrate excellent interpersonal skills when dealing with internal and external customers, including Clinical Suppliers/Consultants.
                  • Demonstrate the ability to identify, analyze and report opportunities for improvements and execute solutions.
                    • Lead project and/or project team, as needed.
                      Job Family: Clinical Affairs / Statistics
                      Division: AVD Vascular
                      Travel: Yes, 5 % of the Time
                      Medical Surveillance: No
                      Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Clinical Quality Manager

Abbott
Santa Clara, CA

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