Commercial Quality Specialist APAC (Point of Care)

Job description

JOB DESCRIPTION:

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Our Point of Care diagnostic portfolio spans key heath and therapeutic areas, including infections disease, cardiometabolic, informatics and toxicology.

Primary Function:

·  Support Commercial Quality System management maintenance in APAC region for our Point of Care (APOC) Diagnostics division
·  Act as a liaison between APOC and its distributors/suppliers across the region
·  This is an individual contributor and report to Quality Compliance Manager APAC

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.

Requirements:

·  Bachelor's Degree in Science/Engineering
·  Minimum of 3 years of QA experience in Medical Device or Pharmaceutical industry preferred
·  Experienced in cold chain product management, CAPA/NC management, quality audits, warehouse management
·  Candidates with experience with China GxP quality systems and post-market survellience are highly advantageous
·  In-depth knowledge of international quality systems and medical device standards, such as ISO 13485, ISO 9001, MDSAP, etc.
·  ASQ Certification (CQA, CQE) or equivalent; specific work experience in quality auditing may be substituted for certificate.
·  Excellent communication skills and strong language fluency in English
·  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.
·  Proficient in use of personal computer and business/technical software (e.g., Microsoft Office), able to use Chinese softwares/systems to manage China country activities.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

     

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:

APOC Point of Care

        

LOCATION:

Singapore > Singapore : DUO Tower

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 15 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)