Established Medical Device company, providing end to end solutions, and intuitive design. Boasting significant growth, and further plans, they are hoping for a Senior Quality Engineer to join an established team.
You will be highly motivated, with strong experience performing quality engineering activities, with the ability to support the development and sustainment of the organisations medical device designs and manufacturing processes.
RESPONSIBILITIES* Establish, implement, and promote; quality planning, design control, process control, verification and validation activities to aid delivery of efficient designs and processes providing safe, effective and compliant medical devices* Review and approve product and process documentation throughout entire product lifecycle * Raise problem reports, Non-Conformity report, Corrective Action and Preventive Actions to address product quality concerns and/or QMS concerns* Ensure risk management process is effective and robust in identifying product and process risks and that risk mitigations are implemented so as to ensure safe and compliant medical devices* Support legal manufacturers documentation requirements and technical enquiries to demonstrate company's state of the art regulatory solutions for applicable markets* Apply and guide others in application of, industry standard statistical techniques to product and process including measurement system analysis, capability assessment, statistical monitoring and control, hypothesis testing, sampling, sample size determination and screening, factorial and response surface modelling; Design of Experiments so as to provide objective, data based analysis and conclusions* Provide and manage the application of problem-solving tools, to achieve documented resolution of technical issues affecting the product or process.
QUALIFICATIONS* Graduate or equivalent calibre in engineering, science or technology discipline* Experience in a quality related field within a Medical Device design environment or equivalent regulatory controlled environment (product development)* Experience in product and process software and hardware V&V. * Experience in control of clean rooms for manufacture.* Sound understanding of risk management techniques including FMEA.* Strong understanding of a range inferential statistical techniques, sampling techniques, MSA, DoE etc; experience of using applicable s/w applications advantageous.* Experience of quickly evolving environment with cross functional team working.* Ability to interpret; technical standards, technical drawings and specifications with a good understanding of metrology and other measurement considerations.* Excellent report writing and presentation skills, good verbal communication skills.* Experience in application of common formal problem-solving techniques.* Experience of Supplier Auditing, ideally within medical device environment. * Experience with Supplier Qualification and Management.
Working with a range of medical device clients, from start-up, SME through to global organisations, we have numerous opportunities within the QARA space. Please contact Holly Evans - email@example.com for more information.
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