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Quality Assurance ManagerAbbott

Free StateSouth Africa
a year0 Applicants
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job description - Quality Assurance Manager

  • The Quality Manager South Africa represents the main interface between Molecular Diagnostics Quality Assurance Division, Commercial and Service & Support Leaders in South Africa responsible to assure full compliance to all Quality related processes and procedures including managing quality activities at local warehouses, spare part depots and distribution centers.
  • Ensures awareness and compliance of new and revised quality processes, documentation and regulations that affect South Africa and other Africa.


  • Ensure Quality System awareness and compliance in South Africa.
  • Achieve results associated with daily business schedule and goals as assigned.
  • Plans and conduct internal audits to verify the effectiveness of the quality management system.
  • Prepares/ coordinate external audits.
  • Ensures purchasing/supplier controls implemented and maintained including quality warehouse oversight, distributor control and maintenance.
  • Responsible for implementing, maintenance and control of 3PL warehouses, distribution center spare part depots in South Africa and other Africa.
  • Responsible for managing Q-holds and temperature excursions, temperature monitoring, supplier audits, procedure creation and supporting incoming quality control at 3PL warehouses, distribution center, spare part depots in South Africa and other Africa.
  • Ensures CAPA management implemented and maintained as well as continues improvements established.
  • Coordinate Field Communications and Vigilance activities for South Africa.
  • Ensures availability of org charts and job descriptions together with HR.
  • Ensures Document Control for local South African procedures and works together locally with the Core Diagnostics on improvement projects, as well as maintaining shared services as applicable.
  • Support/provide training to the organization about the Molecular Diagnostics Quality System.
  • Support Management in consulting QMS training requirements.
  • Input Management Review for the Commercial Affiliates.
  • Act as Liaison between Abbott Molecular Regulatory, Commercial, and divisional and inter-divisional functions.
  • Supports other affiliates and projects in EMEA with the quality knowledge as deemed to be required.
  • Participates in AQR South African inter-divisional meetings, ensuring compliance to local regulations and GxP practices.



  • A tertiary qualification in Biochemistry OR Chemistry OR Quality OR related.
  • Additional Quality training is Advantageous.


  • 5-7 Years’ experience in a similar role is essential, having worked in MEDICAL DEVICES or PHARMACEUTICAL
  • Must have strong experience with ISO 9001 and/or ISO 13485
  • Must have strong attention to detail and be self-motivated.
  • Experience having dealt with countries outside of South Africa would be beneficial
  • Deep understanding of Quality Systems management, Warehouse control and GxP.
  • QMS auditing experience desired.
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