Quality Engineer Medical Devices in Wotton-under-Edge

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 requirememts

• 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.

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