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Senior Quality Engineer - R7089

Charfield

Job Description A vacancy has arisen for an experienced Senior Quality Engineer working within medical division based in Charfield, Glouc. The successful candidate will be required to provide Quality Engineering support for manufactured or subcontract manufactured current and development products, these include a drug delivery system (neuroinfuse), surgical planning software (neuroinspire) and devices supporting neurosurgery. Key tasks will include the review and/or generation of requirements and specifications, validation protocols/reports, risk management and design change documentation, as well as CAPA and non-conformity support. The successful candidate will be required to work closely with the development and manufacturing teams based in Gloucestershire and Swords (Ireland). Therefore, some travel is a requirement of the role. The candidate will be required to be on-site a minimum of 3 days a week. Responsibilities Collaborates with project team members in new product development and product design change activities, to deliver products to market in compliance with requirements and regulations. Support the project team in validation and risk management activities, and in the generation of other documents required for the Design History Files. Review and approve change control records. Provide Quality Engineering support for activities including non-conformities and CAPAs. Identify and implement process improvements. Depuitse for the Quality Manager as and when required. Key requirements Detailed knowledge of ISO13485 and 21CFR Part 820 Quality System Regulation (QSR). 5+ years’ experience in a Medical Device Quality Engineering role. Experience in Risk Management tools and techniques to ISO 14971. Experience in a design and development project team. Experience of change control. Knowledge of validation activities. Nonconforming product management, CAPA root cause investigation. Able to understand hardware and software requirements and specifications. Able to work collaboratively, with appreciation for all stakeholder requirements. Excellent communication skills and attention to detail. Desirable requirements Life science, engineering, medically related degree or appropriate experience. Knowledge of Quality tools and statistics. Experience in neurological or drug delivery devices. Additional validation experience (process, equipment, cleaning, sterilisation, Test Method Validation). NPI. Knowledge of injection and extrusion moulding processes. Internal / Lead Auditor trained to ISO 13485. Knowledge of IEC 60601. The successful candidate for this role should be Organised and self-motivated. Detail-oriented with excellent communication skills. Open to change. A team player, yet self-determined with a strong emphasis on quality. Able to work to strict deadlines and encourage others to do the same. Additionally, travel to subsidiary sites and suppliers will be required. This role demands a balance of individual initiative and team collaboration. Benefits When you join Renishaw, we're committing to your future career. That's because we believe in developing our people's skills and promoting them internally. We also offer a benefits package that's highly desirable; including a 9% non-contributory pension, discretionary annual bonus, *subsidised onsite restaurants and *coffee shops, free parking, *car sharing scheme and *24 hour fitness centres. (*not available at our Castle Donington, Exeter, York & Edinburgh sites). We also want to promote a healthy work-life balance as much as possible, so we have introduced a hybrid working policy which allows for a combination of home and office based working depending on the nature of your role. We also offer a variable working programme, 25 days holiday plus bank holidays, Life Assurance policy of 12 times annual salary, Cycle to Work scheme, enhanced maternity pay subject to qualifying criteria, Health Cash Plan, the option to join BUPA Renishaw Health Trust and an Employee Assistance Programme for employees and family. Please click here for further information about our benefits. At Renishaw we believe that our success is powered by welcoming a workforce of diverse and talented people. Through encouraging an inclusive culture, where all our employees are free to be themselves, we can achieve our core values: Innovation, Inspiration, Integrity, and Involvement. If you are excited about the role but feel as though you don’t meet all the requirements, we would encourage you still to apply. You might just be the right person for this role or another opportunity at Renishaw. We are committed to providing reasonable adjustments to make interviews and jobs more accessible. Should you have any difficulty during the recruitment process, or require any reasonable adjustments please contact the recruitment team on 01453 524600 or recruitment@renishaw.com. Please click here for further information about diversity and inclusion at Renishaw. Employment Type: Permanent Time Type: Full time Requisition Number: R7089 Senior Quality Engineer (Open) Renishaw is a FTSE 250 global engineering and scientific technology company, with core skills in measurement, motion control, additive manufacturing, healthcare, spectroscopy and manufacturing. We supply products and services that push the boundaries of what is possible in applications as diverse as jet engine and wind turbine manufacture, through to dentistry and brain surgery. We are also a world leader in the field of metal additive manufacturing (also referred to as 3D printing), where we design and make industrial machines that ‘print' parts from metal powder. We currently have 77 offices in 36 countries, with around 5,200 employees worldwide. Over 3,000 people are employed within the UK where we carry out the majority of our research and development, and manufacturing. With a global presence in a broad range of sectors, we aim to ensure that our workforce reflects the diverse global communities we serve. Every year we welcome a wide range of new employees, from apprentices to experienced professionals. By joining Renishaw you will be making a difference to the world in which we live, in a global company that encourages innovation and personal achievement. Our people help us to pursue this purpose so that we can continue to be a world leader in precision technology and deliver on our vision to innovate and transform capabilities in manufacturing, science and healthcare through unparalleled levels of precision, productivity and practicality.

 

 

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