JOB DESCRIPTION:
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.
The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
AMD Molecular
LOCATION:
Taiwan > Taipei : Mingsheng Commercial Building
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
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