QA Specialist APAC

Job description

JOB DESCRIPTION:

Summary:

·  Support Commercial Quality System management maintenance in APAC region
·  This is an individual contributor and report to Quality Compliance Manager APAC

Attractive Features of Company and This Position:

At Abbott, you can have a good job that can grow into a great career. We offer:

·  Training and career development, with onboarding programs for new employees
·  Financial security through competitive compensation, incentives plans
·  Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
·  Paid time off
·  The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Responsibilities:

·  Distributor Management
·  Perform audit and approval of distributors as part of the distributor selection, qualification, and approval process. This includes audit scheduling and execution, audit report preparation and the follow-up of distributor corrective actions.
·  Prepare, co-ordinate the sign-off for distributor Quality Agreement to ensure robust partnerships exist.
·  Communicate and train distributors on APOC quality requirements.
·  Maintain Approved Distributor List and performance profile, including change control, report card issuance etc.
·  Quality Management System Maintenance
·  Support CAPA management and follow up action per assignment.
·  Support Management Review process including material preparation and document filing.
·  Support internal & external audits
·  Support supplier management per needs including audit, performance monitoring, etc.
·  Keep vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
·  Work closely with relevant Divisional functions and local cross functional team to support business needs.
·  Perform other duties & projects as assigned.

Qualifications/ Experience:

·  A minimum of 3 years of QA experience in Medical Device or Pharmaceutical industries
·  Experience in cold chain product management, CAPA/NC management, Audits, warehouse management are preferred.
·  In-depth knowledge of international quality systems and medical device standards, such as ISO 13485, ISO 9001, MDSAP, etc.
·  Excellent verbal communication skills appropriate for acting as a liaison between APOC and its distributors/suppliers including China distributors
·  Ability to work independently and in groups; ability to work cross-functionally; ability or aptitude to exercise judgment within defined procedures and practices to determine appropriate action.
·  Ability to work independently with minimal supervision. Ability to work and interact with multiple cultures in different time zones.
·  Be proficient in use of personal computer and business/technical software (e.g., Microsoft Office), dule to use Chinese softwares/systems.
·  Fluently English language skill both written and spoken.
·  Experience in China GSP and MD post-market management are preferred.

Qualifications

·  Apprenticeship or Bachelor's degree in Life Science, Engineering, or closely related discipline is required OR relevant combination of education or experience.
·  ASQ Certification (CQA, CQE) or equivalent; specific work experience in quality auditing may be substituted for certificate.

Mobility: 15% travel

     

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:

        

LOCATION:

China > Shanghai : 388 W. Nanjing Road, Ciros Plaza

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 15 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable