Job Information
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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