Research and Development Technical Specialist

GBUK Ltd; York and North Yorkshire; On-site; GBP 35,000 - 52,000; Full time

Job summary

GBUK is seeking a technically-minded professional to join our quality and R&D team in the UK. You will coordinate investigations into product performance, complaints and non-conformances, working with external manufacturing partners to uphold specifications.

You will support root-cause analysis, CAPA actions and product testing, ensuring documentation remains current and compliant. You will contribute to audits, provide guidance, escalate safety concerns when needed, and seek continuous

Qualifications

• Experience in a technical, quality or R&D environment in medical device, pharmaceutical or food manufacturing.
• Knowledge of ISO13485.
• Strong analytical and investigative abilities with high attention to detail.
• Confidence communicating with internal teams and external partners.
• Good IT skills, including MS Office.
• A full UK driving licence and access to a vehicle.

Responsibilities

• Coordinate investigations into product performance, complaints and non-conformances.
• Work with external manufacturing partners to investigate issues and maintain specifications.
• Support root-cause analysis and CAPA actions.
• Plan and execute product testing; write protocols, analyse data and prepare reports.
• Keep product specifications and technical documentation current and compliant.
• Support internal and external audits and provide technical guidance as needed.
• Escalate product quality or patient safety concerns appropriately.
• Identify opportunities to improve products, processes and ways of working.

Skills

Analytical skills

Investigation skills

Communication skills

IT literacy

Driving licence

Education

Science/Engineering/Medical degree (Desirable)

Job description

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.