Quality Systems Specialist

Job description

     

JOB DESCRIPTION:

Position:      Quality Systems Specialist

Division:       Abbott Diagnostics division

Reports to:  Quality Assurance Manager

Location:     Johannesburg

Primary Objective of Position

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

QUALIFICATIONS AND EXPERTISE :

Education:

A tertiary qualification in Biochemistry OR Chemistry OR Quality OR related.

Experience :

A minimum of 2 years’ 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

     

JOB FAMILY:

Operations Quality

     

DIVISION:

        

LOCATION:

South Africa > Johannesburg : Abbott Place

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable