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A vacancy has arisen for an experienced Senior Quality Engineer working within the medical division based in Charfield, Gloucestershire.
The successful candidate will be responsible for providing 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 reviewing and/or generating requirements and specifications, validation protocols/reports, risk management and design change documentation, as well as CAPA and non-conformity support.
The candidate will need to work closely with development and manufacturing teams based in Gloucestershire and Swords (Ireland). Some travel is required, and on-site presence is expected at a minimum of 3 days a week.
Responsibilities
1. Collaborate with project team members in new product development and design change activities to ensure products meet requirements and regulations.
2. Support validation and risk management activities and generate documents required for the Design History Files.
3. Review and approve change control records.
4. Provide Quality Engineering support for non-conformities and CAPAs.
5. Identify and implement process improvements.
6. Assist the Quality Manager as needed.
Key requirements
* In-depth knowledge of ISO 13485 and 21 CFR Part 820 QSR.
* 5+ years of experience in a Medical Device Quality Engineering role.
* Experience with Risk Management tools and techniques per ISO 14971.
* Experience working in a design and development project team.
* Knowledge of change control processes.
* Understanding of validation activities.
* Ability to understand hardware and software requirements and specifications.
* Strong collaboration skills and stakeholder awareness.
* Excellent communication skills and attention to detail.
* Degree in life sciences, engineering, medical field, or equivalent experience.
* Knowledge of quality tools and statistics.
* Experience with neurological or drug delivery devices is preferred.
* Experience with NPI processes.
* Knowledge of injection and extrusion moulding processes.
* Training as an internal or lead auditor for ISO 13485.
* Knowledge of IEC 60601 standards.
The ideal candidate should be
* Organized and self-motivated.
* Detail-oriented with excellent communication skills.
* Open to change and adaptable.
* A team player with a focus on quality.
* Capable of working under strict deadlines and motivating others.
Travel to subsidiary sites and suppliers will be required. The role balances individual initiative with team collaboration.
Joining Renishaw offers career development opportunities, a competitive benefits package—including a 9% non-contributory pension, discretionary bonus, subsidized onsite restaurants and coffee shops, free parking, car sharing scheme, and 24-hour fitness centers (availability varies by site). We promote a healthy work-life balance with a hybrid working policy, flexible hours, 25 days holiday plus bank holidays, life assurance, cycle-to-work scheme, enhanced maternity pay, health cash plan, BUPA health trust, and employee assistance programs.
Further information about our benefits, diversity, and inclusion can be found on our website.
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