Abbott

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