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Abbott Sr. QA Specialist, TW/HK in New Taipei City, China

Main Responsibilities:

  • Ensure Quality System awareness and compliance in Taiwan

  • Achieve results associated with daily business schedule and goals as assigned.

  • Plan and support internal and external audits to verify the effectiveness of the management system

  • Ensure purchasing/supplier controls implemented and maintained including quality warehouse oversight and maintenance (e.g. Quality Holds, Traceability, Pest Control, Labeling Activities, Quality Agreements, Quality Plan, Supplier & Distributor evaluation/ monitoring).

  • Ensure that post-market surveillance activities are executed as per communications from Divisions, and ensures that activities are properly communicated to the Molecular Diagnostics area team for awareness.

  • Prepare/coordinate internal and external audits.

  • Ensures CAPA management implemented and maintained.

  • Ensure availability of organizational charts and job descriptions together with HR.

  • Ensures Document Control for local Taiwan procedures.

  • Support/provides training to the organization about the Abbott Molecular Quality System.

  • Support Management in setting-up Training Plans for all positions.

  • Act as Liaison between Abbott Molecular Regulatory, Commercial and divisional and inter-divisional functions.

  • Provide support for quality activities within the organization, as needed.

Skills & Experience Required:

  • BS degree in medical or Human-/Bio-/Life Science related discipline, advanced degree is a plus

  • 3+ years QA related experience in medical devices/ In Vitro Diagnostics/ or Molecular Diagnostics industry.

  • The experience on GMP process (including implementation and maintenance of GMP) is a must.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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