Quality Assurance & Regulatory Affairs

Quality Assurance & Regulatory Affairs


Quality Assurance & Regulatory Affairs

Details of the offer

The above varied and challenging position exists for a suitably qualified, high energy performer with dri ve, reporting to the Chief Financial Officer.

The successful candidate must :

• Have a Bachelor Degree or other relevant qualification;
• Have a minimum of 5 years’ experience in quality control and servicing within the medical equipment
industry, or similar and applicable environment;
• Have had exposure to internal and external audits;
• Have good root cause analysis exposure;
• Have good communication skills (written and verbal);
• Be a team player with the ability to maintain independent approach and assume accountability.

The Core responsibilities will be :

ISO 9001

• Fulfil the requirements of Quality Systems Manager as per ISO 9001;
• 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 9001 system and address timeously any major and/or minor nonconformances raised;
• Ensure management meetings are held on a regular basis in compliance with set frequencies;
• Provide a monthly risk assessment report on the effectiveness of the QMS.

ISO 13485

• Establish the requirements for compliance with ISO 13485 in accordance with applicable frameworks;
• Ensure compliance with the requirements of ISO 13485;
• Perform regular internal audits to ensure compliance with specific ISO 13485 requirements;
• Provide a monthly risk assessment report on the effectiveness of the QMS.

General Business Risk Assessments:

• Conduct Supplier Risk Assessments when required;
• Perform customer surveys as required to establish trends. Analysis to be performed against standard company quality assessment parameters. (Alternate parameters to be recommended where necessary);
• Ensure equipment used in technical is calibrated and safe for use;
• Manage the process for Incident Reporting and ensure confidentiality at all times;
• Manage applicable legislative requirements in terms of Labour Inspections;
• Recall procedure exposure;
• Knowledge of infection control procedures.

Health and Safety Officer Duties:

• Perform the tasks and assume responsibility as Company Health and Safety Officer;
• Assume full responsibility for Health and Safety Issues in the company, including First Aid, Fire and Evacuation drills. (e.g., scheduling and ensuring fire prevention devices are maintained, signage is clear and visible, fire department inspections, etc.);
• Ensure compliance with applicable Health and Safety Requirements for all sites, branches (locally and abroad);
• Prepare all necessary documentation and provide necessary guidance in terms of all health and safety requirements for projects and other site installations, including but not limited to site risk assessments, representative appointments, assignment of responsibility etc.

Other Legislation Compliance:

• Keep abreast of industry developments on applicable and relevant legislations, including but not limited to
MARS Act, Department of Radiation Regulations, etc;
• Liaise with Product Managers and compile the required documentation files for registration of products in accordance with specific requirements of Department of Radiation, and maintenance of registration register;
• Communication of industry developments in a monthly report, and highlight immediately any risks the company may be facing;
• Knowledge of SAHPRA (previously MCC) legislation/regulations.

Source: Executiveplacements


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