Quality Engineer Team Lead in the Blackpool area for a 12month contract. This role provides Quality Engineering leadership to site manufacturing processes by maintaining and developing the Quality System. This includes the procedures and records required for the development, validation and production of CMW products and processes in order to assure the ongoing quality of products and maintain compliance with ISO 9000, ISO13485, FDA QSRs and the Medical Devices Directive. Duties & Responsibilities (leadership, people development, planning and execution) * · Lead the quality activities for all product and process validation activities. Develop and maintain state of the art protocols and procedures and ensure correct implementation across site. Provide technical expertise for all areas on relevant IQ/OQ/PQ protocol issues. Maintain and lead the Site validation master plan * Lead Quality Engineering effort for all manufacturing processes. This will include managing projects designed to identify and implement process improvements within the area. * Provide the Quality effort for all New Product Development activities to ensure that all Quality aspects of process design are addressed. Document and maintain in good order all relevant sections of Device Design History File and DMR as directed. * Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity. Work with Production and Technical Support to develop and implement appropriate process control plans. * Partner with Supplier Quality, Technical Support, Design QE and Purchasing to ensure that all Supplier generated products and components are compliant. * Partner with Supplier Quality, Technical Support, Design QE and Purchasing to ensure that all Supplier generated design changes managed and documented in a compliant manner. * Ensure compliance with all Documented Quality system, FDA QSR's and ISO 13485 requirements during day to day and assigned audit/CAPA activities. * Maintain a good level of housekeeping in designated areas, and observe all Health and Safety at work requirements. Operate within the company's standard procedures where applicable, and review, maintain and create appropriate procedures for sphere of activity. Our client is looking at interviewing candidates next week with a view to start immediately if you are interested then please forward me your current CV. Rates to be discussed. To find out more about Huxley Associates, please visit
www.huxley.com 