Quality Lead Apac

2 weeks ago

Central Singapore Abbott Laboratories Full time
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.


Abbott Molecular is a leader in molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level.


Primary Function:

  • The Molecular Diagnostics Manager Quality Assurance area APAC is responsible for implementing and maintaining the effectiveness of Abbott ́s Quality Management System in the defined geographic area.
  • The area Quality Manager represents the main interface between Molecular Diagnostics Quality Assurance Des Plaines, Core Diagnostic Quality and Regulatory Representative as well as Molecular Diagnostics Commercial and Service & Support Leaders in the area responsible to assure full compliance to all quality related processes and procedures.
  • Lead indirect report to manage country specific quality system related activities.

Major Responsibilities:

  • Improves and maintains the quality system in the area of Asia Pacific (APAC).
  • Ensures training and development for functional area is provided and documented.
  • Prepare country organizations for division level, corporate and external quality system audits. Continuous consideration of process improvements and implementation.
  • Responds to all Division/Area audit findings with proposed corrective and preventive actions within defined period, follows up on the implementation and effectiveness of actions taken.
  • Priority and resource Management including managing shared services
  • Prepare country organizations for division level, corporate, internal and external quality system audits.
  • CAPA SME within the Molecular Diagnostics area commercial affiliates, including One Abbott representative.
  • Act as coordinator between QA Des Plaines, local Molecular Diagnostics countries and Core Diagnostics Quality Representatives for complaint related tasks such as Field Action communication, Field Advisory Notices and related effectiveness checks and participate to the execution of required customer communications.
  • Actively support country organizations, customers and distributors with appropriate answers in all quality related questions.
  • Supporting Commercial Area Management Review and documents outcome.
  • Identifies potential quality issues.
  • Ensures support of product
- and cost improvements, new product launches and transfers.

  • Implementation and maintenance of operating procedures relevant to the area.
  • Lead projects and continues improvement initiatives.
  • Communicates and cooperates with coworkers, other departments and other Abbott divisions as needed and manages indirect reports.

Requirements:

  • Bachelor's Degree in Science/Engineering or related disciplines
  • Minimum of 1012 years of Quality Assurance experience in regulated industry, preferably diagnostics/medical devices/pharma/healthcare industry.
  • Excellent knowledge of the Quality System with understanding of the CAPA system and interrelated systems with an awareness of current processes and procedures as it relates to MDx Quality System and CAPA system.
  • Must be able to influence, inspire, coach, and advise people on all Quality relevant aspects while complying with all policies and procedures of the Quality System impacting the commercial affiliates.
  • Fluent oral and written English.
  • Strong leadership, communication and organization skills.


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.

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