Compliance and Quality Assurance Manager - Sandton
Innovative medical devices manufacturer is looking for Compliance and Quality Assurance Manager to ensure that SANAS, ISO, FDA and CE quality initiatives are implemented and achieved.
• BSC Engineering Degree/MBA/Technical Degree
• Registration with a Professional society would be preferred
• A minimum of 4 years Quality Assurance experience
• Knowledge of international Bodies and training would be beneficial.
• Experience in implementation of Quality Procedures
• Experience in Systems Development
• Knowledge of ISO 19011, IEC 17020, ISO 13485
• Knowledge of TR 78, SANAS and Department of Health Inspection Body Requirements
• Knowledge of inspection requirements
• Knowledge regarding technology used for the manufacture of products to be inspected, the operation of processes, delivery of services, and the way these occur
• Knowledge of defects that may occur during product use, failures in process operation and service delivery deficiencies
• Knowledge regarding the significance of deviations found in regards to product use, process operations and service delivery
• Ensuring compliance to regulatory requirements in the following countries: RSA, EU, USA and others
• Develop, implement and maintain Quality Management System.
• Develop and maintain Documentation
• Facilitate establishment and maintenance of Departmental Operating Documentation such as policies, procedures, work instructions, manuals etc. and review and approve such documentation.
• Facilitate establishment and maintenance of Product Documentation such as guidelines and work instructions and review and approve such documentation.
• Co-ordinate and regulate the use of Logo’s (i.e. Marketing Materials)
• Monitor External Documents
• Monitor implemented Process Performance and report in Management Review.
• Monitor and facilitate Improvement in the following areas: Continuous Improvement, Notified Body Audit, Vigilance System, Fault reporting and corrective action system (FRACAS, Internal and Supplier Audit, Breakthrough Improvement, Product, Management System, Infrastructure
• Perform internal audit of the QMS
• External SGS Audit
• Internet-based QMS Maintenance
• Achieve and maintain systems Inspection Body SANAS Accreditation and Department of Health IB Licence.
• Annual Internal Audit
• Annual Management Review
• Annual SANAS audit
• Quality System Audit
• Technical Signatory Assessment
If you match ALL the requirements, please send your cv along with at least 2 contactable references AND a motivation for your application.