Job Summary
Responsibilities:
Investigating quality complaints in full, with accurate and detailed reporting.
Providing timely and high-quality feedback to all stakeholders.
Monitoring complaints, deviations, change controls, and CAPAs on TrackWise and following up where results are outstanding. Ensuring that the identified root causes and, where applicable, corrective actions are of high quality and adhere to the company standard.
Assisting with implementing ISO 13485:2016 and aligning processes with the necessary requirements.
Possible assistance with QC release of local products.
Effectively maintaining the internal supplier audit program according to ISO.
Assisting with supplier reviews and optimization programs.
Reporting on Audit, deviation, and CAPA trends monthly through to management.
Requirement
- A qualified chemist with a tertiary education in Science
- A minimum of a BSc. Qualification in Quality auditing in ISO 9001 and ISO 13485, with at least 100 hours of auditing and a minimum of 2 years of lead auditing experience.
- Relevant quality-related degree is desirable.
- A certificate in various courses, including handling hazardous materials, good laboratory/manufacturing practices, is advantageous.
Please note only shortlisted candidates will be contacted