Description
Validation Engineer 6 months @ £33.15 Blackpool Part of the Quality team reporting into the Plant Quality Manager.
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 for all DePuy CMW. 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 site wide activities aimed at maintaining Part 11 Compliance. 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. Job Specific Competencies Ability to communicate & present (in all its forms) and co-operate effectively at all levels across the organization.
Well developed organizational skills and people development skills. Attention to detail and excellent time management. The ability to work to a deadline, to cope under pressure and react to changing requirements. The ability to work as part of a team to achieve results An effective leader of the QE team with relevant experience in all areas within the QE role Manage personal workload and assist the wider group in managing conflicts and Bottlenecks Team performance management on regular basis Proactive leader GLP Competencies Credo Values: Integrity & Credo Based Actions Customer Focus: Results & Performance Driven & Sense of Urgency Innovative Solutions: Big Picture Orientation with Attention to Detail & Intellectual Curiosity Talent Development: Collaboration & Teaming & Self-Awareness & Adaptability
Skills RequiredEssential Demonstrable high level knowledge of product and process validation including Part 11 Sound knowledge of cGMP and regulatory standards. Must be experienced with working within a regulated environment; a working knowledge of ISO9001, ISO13485 and/or FDA Quality System Regulations would be an advantage. Desirable Ideal candidate will be a Black belt or have experience in the use of SPC techniques, Gage R&R, First Article Inspection etc. Ideal candidate will have a polymer processing or chemical engineering background with a proven ability to interpret and create specifications and procedures. Knowledge of the medical device (or closely-related, healthcare, etc) industry