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 email@example.com. If you do not hear from us within 2 weeks, please consider your application unsuccessful.