Title QUALITY ASSURANCE & REGULATORY AFFAIRS MANAGER
Categories Gauteng
Salary R35k – R40k
Location Johannesburg
Job Information

Ref 6572.

A leading medical devices company has an opening for a Quality Assurance and Regulatory Affairs Manager to fulfill the requirements of Quality Systems Manager as per ISO 9001.

Duties include, but are not limited to:

  • Design documentation and rollout quality management practices in compliance with documented company policies and procedures.
  • Ongoing staff training on quality management systems and company practices.
  • Ensuring compliance to QMS through conducting regular internal reviews/audits.
  • Facilitating the external audit on ISO 9001 system and timeously addressing any major and/or minor non-conformance raised.
  • Establishing the requirements for compliance with ISO 13485 in accordance with applicable frameworks.
  • Conducting Supplier’s Risk Assessments when required.
  • Managing applicable legislative requirements in terms of Labour inspections.
  • Performing tasks and assuming responsibility as a company Health & Safety Officer.
  • Assuming full responsibility for Health & Safety issues in the company, including First Aid, Fire and Evacuation drills.
  • Keeping abreast of industry developments with regard to applicable and relevant legislations, including but not limited to MARS Act, Department of Radiation Regulations, etc.

Skills and Requirements:

  • Bachelor’s Degree or other relevant qualification.
  • Minimum of 5 years experience in Quality Control and servicing within the medical equipment industry, or similar and applicable environment.
  • Exposure to internal and external audits.
  • Good root cause analysis exposure.
  • Knowledge of SAHPRA (previously MCC) Legislation and Regulations.
  • Knowledge of Infection Control Procedures.

If you have the above experience and meet the company’s skills and tertiary requirements, please email a copy of your CV to cvgauteng@etalyons.co.za.  If you do not hear from us within 2 weeks, please consider your application unsuccessful.

 

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