investigations into product performance, customer complaints and non-conformationCoordinating R&D actions relating to CAPAs, change controls and quality investigations, ensuring activities are completed accurately and on time.
Working closely with external manufacturing partners to investigate issues and maintain accurate product specifications.
Supporting root cause analysis and implementing effective corrective and preventive actions.
Planning, coordinating and carrying out product testing, including writing protocols, analysing data and producing technical reports.
Ensuring product specifications and technical documentation remain current and compliant.
Supporting internal and external quality and regulatory audits.
Providing technical guidance and training to colleagues where required.
Escalating product quality or patient safety concerns appropriately.
Identifying opportunities to improve products, processes and ways of working.
About you:
We're looking for someone who enjoys working with technical detail and has a collaborative approach to problem-solving.
Essential
- Experience working within a technical, quality or R&D environment in the medical device, pharmaceutical or food manufacturing industries.
- Working knowledge of ISO13485.
- Strong analytical and investigative skills with excellent attention to detail.
- Confidence communicating with both internal teams and external manufacturing partners.
- Good IT skills, including Microsoft Office.
- A full UK driving licence and access to your own vehicle.
Desirable
- A degree in a scientific, engineering or medical discipline.
- Knowledge of Medical Device Regulation (MDR), MDCG guidance and relevant UK, EU or FDA regulatory requirements.
- Familiarity with ISO 14971 (Risk Management), ISO 10993 (Biological Evaluation) and other applicable medical device standards.
- Knowledge of regulations and standards relating to In Vitro Diagnostic (IVD) devices.
What success looks like...
- Technical investigations are completed thoroughly and within agreed timescales.
- CAPAs, non-conformances and change control actions are delivered on time.
- Product specifications remain accurate, controlled and up to date.
- Products continue to meet regulatory, quality and customer requirements.
- Continuous improvements are identified and implemented across products and processes.
Why join GBUK?
GBUK is a leading medical device manufacturer supplying innovative healthcare solutions to customers across the UK and internationally. Our products make a real difference to patients every day, and our people are at the heart of everything we do. When you join GBUK, you'll become part of a collaborative team where innovation, continuous improvement and professional development are encouraged. You'll have the opportunity to contribute to meaningful projects, work alongside experienced technical professionals and help shape products that improve lives.
Our Values:
- Integrity - We do the right thing.
- Collaboration - We achieve more together.
- Innovation - We continually look for better ways to improve.
- Solutions Focused - We solve problems with purpose.
- Adaptability - We embrace change and new opportunities.
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Research and Development Technical Specialist employer: GBUK Ltd
GBUK Ltd is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration within the healthcare sector. With a strong focus on employee growth, the company provides ample opportunities for career advancement while allowing Area Sales Managers the autonomy to effectively manage their territories in the beautiful regions of Gloucestershire, Wiltshire, and Somerset. Join us to be part of a team that values your contributions and supports your professional journey in making a meaningful impact on patient care.
