Research and Development Associate
At GBUK, we’re passionate about developing high-quality medical devices that improve patient care across the world. As our R&D Technical Associate, you’ll play a key role in ensuring our products continue to meet the highest standards of quality, safety and regulatory compliance.
Working closely with colleagues across Research & Development, Quality Assurance and Manufacturing, you’ll lead technical investigations, coordinate product improvements and help ensure our products remain compliant throughout their lifecycle.
If you enjoy solving technical problems, working collaboratively and making a tangible impact on patient safety, we’d love to hear from you.
Location: Head Office, Selby, North Yorkshire
Department: Research & Development / Quality
Full Time | Permanent
As an R&D Technical Associate, you’ll be responsible for supporting the ongoing quality, performance and compliance of GBUK products by:
- Leading investigations into product performance, customer complaints and non-conformation
- Coordinating 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.
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.
