Senior QA Validation Specialist

The purpose of this role of Quality Validation Specialist is to ensure product and system quality. Your will be evaluating engineering systems based on safety and performance standards and analyse results and update activity logs

• Design or plan validation protocols and other documentation for equipment, processes or products meeting internal and external safety and quality requirements.
• Conduct validation or qualification tests for new or existing processes, equipment or products in accordance with internal protocols, procedures or external standards.
• Lead and provide an analysis of data by using software such as Minitab or similar on the results of test data to show the necessary quality performance stability requirements have been met.
• Managing the sites Validation Master Plan and Calibration Master Plan.
• Perform product testing in the laboratory which includes determining appropriate test methods, housekeeping, maintenance of test equipment and well as testing and monitoring protocols and record-keeping as required.
• Review and revise specifications for products and processes, including creating drawings in Easy Cad software.
• Supporting the Quality Manager with ensuring that the quality management system as defined in ISO 13485 is implemented and maintained.
• Write or review Standard Operating Procedures or Work Instructions and other quality documentation as necessary.
• Maintain a technical skills profile to meet the needs of the business.
• Provide a lead in problem solving, supplying targets for yield improvements, conducting failure and root cause analysis including risk assessments and FMEA activities.
• Support the management, investigation and analysis of Supplier and Customer quality complaints; support the maintenance of the customer complaint database and ensure that complaints are dealt with effectively.
• Support and manage corrective and preventative action initiatives as necessary.
• Support with training as required on topics related to Quality and the quality system.
• Support robust and timely audit activities across the Company, including procedural, process and product audits and that necessary corrective measures are put in place; this includes hygiene audits.
• Support New Product Development processes, including labelling, specifications, customer requirements, etc. in cooperation with Regulatory Affairs.
• Implement improvements to production processes that lead to overall increases in product quality.
• Support incoming, intermediate and final inspection of output is effective and product properties meet quality requirements.
• Ensure effective communication between other departments in the provision of quality information and requirements.
• Other duties as necessary to support the operations of the Quality and Regulatory Affairs Department.