Quality Assurance & Regulatory Affairs Manager

Updated: April 09, 2024 04:02 PM GMT

Unique Personnel

Brakpan

Reporting to the Chief Financial Officer

Core Activities

Quality Management (ISO 9001 & 13485):
• Fulfil the requirements of Quality Systems Manager as per ISO 9001/13485;
• Design, documentation and rollout of quality management practices in compliance with documented company policies and procedures;
• Alignment of adopted company policies and processes to best practices of similar industries;
• Implementation and monitoring of quality management system (QMS) through a central reporting database (Central CPAR System);
• Ongoing training of staff on quality management system and company practices;
• Ensure compliance to QMS through conducting regular internal reviews/audits;
• Timeously address corrective actions raised, give feedback and facilitate the implementation of controls or practices to prevent reoccurrence;
• Appoint and train internal ISO audit managers;
• Facilitate the external audit on the ISO system and address timeously any major and/or minor non-conformances... More Detail