Quality Specialist

• Ensuring that area procedures are correct and updated as necessary.
• Review of document change requests to evaluate each change for quality related issues.
• LMS administrator for QA function.
• Assist in the development and maintenance of the quality system as required, ensuring compliance to ISO13485:2003.
• Provide guidance to Technical Service and Customer Service on quality system issues.
• Contribute to making the operation efficient and compliant by effective liaison with all departments in quality matters.
• Facilitate internal audits of the systems and processes on a regular basis as performed by the internal audit team. Act as Lead Auditor.
• Participate and report at management review and assist in resolving issues that may arise.
• Conduct QMS training for all employees.
• Participate in the development of the department KPIs. Assist in the preparation of internal statistical reports (KPIs).
• Schedule, chair and report at routine quality focused meetings influencing change and developing best practices.
• Function as QA support in handling Corrective and Preventive Action requests in the internal CAPA system.
• Liaise with external groups in relation to complaint handling systems i.e. complaint investigation centres and complaint management centres.