JOB DESCRIPTION:

ABOUT ABBOTT:

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 130 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 114,000 of us are working to help people live not just longer, but better, in the more than 160 countries we serve.

Rapid Diagnostics (RDx), is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. This position is within our Infectious Diseases Business.

RESPONSIBILITIES:

• This role is of Commercial Quality Leader for South Korea.
• Accountable for being Management representative with Responsibility & Authority for the Quality and Regulatory requirements; ensuring compliance to Abbott Global Quality/Regulatory Framework, Divisional Policies/ Procedures.
• Responsible for proactively creating Quality Culture w.r.t People, Process, Products & Services to meet customer needs.
• Maintain QMS in the market and continually evaluate and monitor the quality system for suitability and adequacy for the commercial business.
• Must interface and represent commercial leader in areas of quality decisions, such as escalations, field actions and/or other significant quality issues.
• Engage as required for the Quality Complaints for Abbott products, ensuring timely investigation, resolution,  closure & customer follow-ups through the Legal Manufacturers and Tech Support Team. Proactively reviewing product complaints and address the trends in a timely manner.
• Collaborate with other global entities in fulfilling Field Corrective actions (FCA) resulted from Regulatory Field Safety Notifications.
• Provide relevant quality support for post market surveillance (PMS) activities, ensure timely executions to minimize, any product supply interruption.
• Facilitating Audits (Corporate Quality Audits, Regulatory Audits, ISO-Notified Bodies)
• Ensuring implementation of effective CAPA program across operational site.
• Driving Supplier Qualification Program (Identification, Evaluation through Audits, Monitoring, Maintenance & Re-Qualification).
• Review/Approve Changes, Deviations, Investigations, Market Complaints & CAPA.
• Responsible for Budgetary Planning for Quality Operations.
• Evaluate the existing Quality Management System implemented in the country with the Abbott QMS and Business Unit Quality Standards and Procedures and conduct gap analysis , develop a remediation plan and drive it  to achieve highest level of compliance.
• Responsible for the Quality Control program for imported products that are distributed in the market
  • Has final decision making responsibility for product release.
  • Has final decision making and reporting responsibilities for field corrective actions.
  • Collect information on product quality and when concerning information is obtained, provide timely written report to appropriate management so that necessary and appropriate measures be taken.
• Responsible for administration of and compliance with all major quality system activities including but not limited to document control, record control, training, CAPA, quality incidents, risk management and internal audit.
• Continuously drive for compliance with Abbott quality standards and regulatory requirements.
• Responsible for management and satisfactory resolution of product issues in a timely manner.  Coordinate cross-functionally to ensure implementation of containment, mitigation, remediation and corrective activities as necessary.
• Coordinate with entity management and facilitate Quality Management Review activities, including quarterly quality objective reporting, escalation of issues with QMS impact and closure of open actions from previous meetings.
• Responsible for coordination and management of site Quality metric tracking, trending and reporting activities.  Assure metrics appropriately characterize the key performance indicators of the quality system.
• This position will be the Commercial Quality representative for internal compliance and 3rd party audits / inspections.  Coordinate and manage all commercial audits in conjunction with the Commercial office lead.
• Implement new or modify existing processes to maintain compliance with local entity, business unit, division, corporate, voluntary standards and regulatory requirements.
• Other duties as assigned.

BASIC QUALIFICATIONS | EDUCATION:

• Bachelor Degree in Pharmacy/Science/Engineering.
• Must have been employed in the Medical Device/Pharmaceutical /In-Vitro Diagnostics/Healthcare industry for a minimum of 6 years.
• Minimum of 10 years of experience in Quality Assurance and /or Compliance in a regulated industry.
• Minimum of 3 years supervisory / managerial experience
• Ability to effectively communicate in Korean and English.

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Quality Assurance

     

DIVISION:

ID Infectious Disease

        

LOCATION:

Korea > Seongnam, Bundang-gu : SPG Building

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 10 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable