Quality Assurance

1 week ago


Johannesburg, South Africa Abbott Laboratories Full time

**Position Title**: Quality Assurance Specialist ( 1 Year contract )**

**Division**:Abbott Core Diagnostics**

**Location**:Johannesburg**

**DO WORK THAT MATTERS.**

At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.

**Abbott Core diagnostics division** provides diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

In this role, as QA Specialist, you will Supports Quality System compliance in a specific region or regions. Supports a specific process or processes for the whole EMEAP as Subject Matter Expert (SME) or its backup

**Major responsibilities**:
- Supports the Manager QA Region to ensure EMEAP and Region Quality System effectiveness and compliance:

- oPerforms internal and supplier audits.
- oSupports / prepares/ coordinates external audits.
- oSupports QS processes: e.g. Field communications, supplier evaluation, audits and CAPA, document control and record keeping..
- Supports the EMEAP common Quality System by
- oBy being responsible for specific processes as SME or its backup e.g. Field communications, supplier evaluation, competence management, Distributor management.
- oParticipates in Quality System improvements and implementation projects
- oMIMS Subject Matter Expert & Procedure Owner which includes
- Review Abbott policies & procedures, and update Quality documentation accordingly.
- Receive audit input and follow QS Document Control Process.

**QUALIFICATIONS AND EXPERTISE**:

- A tertiary qualification in Biochemistry OR Chemistry OR Quality OR related.
- A minimum of 2 year’ experience in a Quality Assurance role within the Medical Devices Industry.
- 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


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