Description
Quality Engineer 6 month Contract £33.15p/h - Blackpool
Part of the Quality team reporting into the Quality Engineering Team Leader. This role provides Quality Engineering support 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)
Perform monthly trending of all NCs that arise within designated production processes. Generate such data as is required for Dashboard reviews as they apply to designated production processes. Ensure all assigned quality actions are investigated, have causes identified and actions plans completed to the agreed schedule, regardless of source. Perform Internal Audits to schedule and complete audit reports and effectiveness reviews. Lead investigations into product or process issues raised within designated production processes, identifying root cause and corrective action plans as required. Partner with Engineering team during the definition and introduction of new or improved processes, ensuring all validation, calibration, risk management and documentation activities are completed. Own Validation Master Plan and Quality validation review activities for designated production processes. Support operations and engineering teams to ensure that Preventive and Corrective Maintenance activities are completed to schedule. Ensure that Critical System Changes are raised for all applicable changes. Work with operations and engineering teams to ensure that process improvement activities including Lean Manufacturing activities are identified and introduced in a compliant manner. Quality and Compliance Related Responsibilities Ensures that all activities are carried out in compliance with all regulations and laws governing business and quality operations. Responsible for ensuring compliance with all local, national, international and company regulations, policies and procedures for Health, Safety and Environmental compliance
Skills Required
Job Specific Competencies
In depth knowledge of Good Manufacturing Practice. In depth knowledge of quality systems and techniques including ISO 13485 and FDA QSRs. Knowledge of Quality toolbox including FMEA, Mind-Map, Root cause investigations, Lean and Six Sigma tools & techniques. Computer literate. GLP Competencies Ability to carry out structured problem solving and Credo based decision making. Ability to communicate effectively at all levels across the business. Ability to build productive relationships at all levels of the organization. Takes a determined approach to problem solving and to make informed decisions. Ability to make complex issues simple. Ability to manage and adapt to changes effectively. Identifies ways of doing things better and faster. Ability to listen effectively and remain open to other's ideas. Ability to express opinions and ideas, verbally and in writing
Qualifications Required
Minimum of degree in scientific discipline
Minimum of 3 years in a quality, technical or manufacturing role in a regulated industry.
Well-developed organisational skills with an ability to work independently.
Working knowledge of ISO9001, ISO13485 and FDA Quality System Regulations an advantage.