A opportunity has arisen for an experienced Senior Quality Engineer working within Renishaw Neurological Solutions based in Charfield, Gloucestershire.
As the successful candidate you will be required to provide Quality Engineering support for 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 non-conformance reports, CAPA, audit, validation protocols/reports, risk management, supplier/vendor management and design change documentation.
You will work closely with the development and manufacturing teams based in Gloucestershire and Swords (Ireland). Therefore, some travel is a required (approx. 5x per annum).
Is this a site based role with the possibility of WFH on Friday.
Detailed knowledge of ISO13485, ISO 14971 and 21CFR Part 820 Quality System Regulation (QSR)
Experience in a medical device Quality Engineering role
Experience in nonconforming product management, CAPA, design change activities and validation activities
Excellent communication skills
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)
Knowledge of injection and extrusion moulding processes
Lead auditor trained
6 sigma green belt or above
As the successful applicant you will be organised and self-motivated, with an eye for detail and excellent communication skills. You will be a team player, yet self-determined with a strong voice for Quality. Able to work to strict deadlines and encourage and facilitate others to do the same is a must.
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 Homeworking 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, the option to join BUPA Renishaw health trust and an Employee Assistance Programme for employees and family.
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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.
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R6298 Senior Quality Engineer (Open)