- Provide Quality Engineering support for activities including nonconformities, CAPA, validation and risk management activities
- Deputise for the Quality Manager as and when required
- Support product design change activities
- Validation support
- Detailed knowledge of ISO13485, ISO 14971 and 21CFR Part 820 Quality System Regulation (QSR)
- 4-6 years' 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)
- NPI
- Knowledge of injection and extrusion moulding processes
- Lead auditor trained
- 6 sigma green belt or above
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Quality Engineer Medical Device - Wotton-Under-Edge, United Kingdom - Renishaw PLC
4 weeks ago
Description
A vacancy has arisen for an experienced Medical Quality Engineer.
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 non-conformance reports, CAPA, audit, validation protocols/reports, risk management and design change documentation.
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.
Location: Charfield, Gloucestershire
Hybrid working: 3days/week onsite
Responsibilities
Key requirements
Desirable requirements
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, the option to join BUPA Renishaw health trust and an Employee Assistance Programme for employees and family.
