The Quality Specialist supports the organisations commitment to delivering safe and effective products by ensuring compliance with ISO 13485 and related regulatory standards. This role focuses on critical quality activities, including particulate counting, equipment calibration, supplier qualification and monitoring, and maintaining the Quality Management System (QMS). Through accurate data collection, environmental monitoring, and proactive supplier management, the Quality Assurance Specialist ensures the integrity of processes and materials, contributing to continuous improvement and delivering high-quality products to customers. Key Responsibilities: Perform routine particulate counting and environmental monitoring in controlled environments Conduct calibration, maintenance, and equipment verification, ensuring all instruments function correctly and within specifications. Support implementing and maintaining the Quality Management System (QMS) to meet ISO 13485 requirements. Review and maintain supplier documentation, such as certificates of analysis, quality agreements, and audit reports. Collaborate with suppliers to address quality issues, ensuring timely implementation of corrective and preventive actions (CAPA). Assist with the investigation and resolve non-conformances, deviations, and complaints. Conduct sampling and testing raw materials, in-process materials, and finished products according to defined procedures. Maintain accurate and complete records of quality-related data, test results, calibration activities, and supplier performance metrics. Assist in creating, reviewing, and revising quality documentation, including procedures, forms, and work instructions. Monitor and maintain cleanliness and compliance in controlled environments, adhering to established protocols. Ensure compliance with established SOPs, regulatory requirements, and safety standards. Provide input into identifying process improvements to enhance product quality and operational efficiency. Qualifications & Experience: .1+ years experience in quality or related discipline preferred The successful candidate will possess the following key attributes: Must have excellent MS Excel skills and be proficient in Microsoft Office Strong attention to detail and strongverbal and written communication skills. Understanding/awareness of Customer requirements in terms of quality and delivery. Ability to impart knowledge in a clear concise manner. Demonstrate working as part of a team with common goals. Decision-making and Reporting skills Skills: Management Electronic Quality Systems Quality System Benefits: Parking Pension Fund Medical Aid / Health Care Group Life Assurance Flexitime Paid Holidays