8 months ago
My client, a pioneering medical devices company, is currently looking for a Quality Engineer to join on a permanent basis during a period of exponential growth within the business. The Quality Engineer should be highly motivated individual with a sense of ownership to lead and perform quality engineering activities to support safe, effective and compliant development and sustainment of the organisations medical device designs and manufacturing processes
Key Job Responsibilities for this position include:
*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.
*Raise problem reports, Non-Conformity report, Corrective Action and Preventive Actions to address product quality concerns and/or QMS concerns.
*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.
Qualifications / Requirements:
*Degree Qualified or equivalent: BSc (Hons.) or BEng (Hons.), ideally in an engineering or related technical 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.
*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 Supplier Auditing, ideally within medical device environment.
*Experience with Supplier Qualification and Management.
The ideal candidate must have worked previously for a medical device company and be highly proactive and results focused with the ability to influence others within the team. They need to have a proven ability to achieve business' targets and possess strong technical problem-solving skill. A self-motivated individual who can work both individually and as part of a team.
Quality Engineer, Warwickshire