Research and Development Technical Specialist

GBUK; Selby; Hybrid; GBP 42,000 - 56,000; Full time

Job summary

GBUK is seeking an R&D Technical Associate to help maintain product quality, safety and regulatory compliance. Hybrid role based at the North Duffield head office, collaborating across R&D, QA and Manufacturing.

You will lead investigations, coordinate CAPAs and change controls, and support audits, with a focus on continuous improvement and patient safety.

Qualifications

• Experience in technical, quality or R&D environments within medical devices, pharma or food manufacturing.
• Working knowledge of ISO13485 and regulatory expectations.
• Strong analytical and investigative skills with attention to detail.

Responsibilities

• Lead investigations into product performance, customer complaints and non-conformance.
• Coordinate CAPAs, change controls and quality investigations with timely delivery.
• Collaborate with external manufacturers to investigate issues and maintain specs.
• Support root cause analysis and implement corrective actions.
• Plan and execute product testing, write protocols, analyze data and report findings.
• Support internal and external audits of quality and regulatory compliance.

Skills

Analytical thinking & investigations

Communication

IT skills

Collaborative problem solving

Quality systems knowledge

Education

Degree in scientific, engineering or medical discipline

Tools

Microsoft Office

Job description

R&D Technical Associate

Location: Hybrid role with some days each week based at head Office, North Duffield, Selby

Help improve medical devices that make a difference.

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.

What you'll be doing

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-conformance
• 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.

About you

We're looking for someone who enjoys working with technical detail and has a collaborative approach to problem-solving.

You'll ideally have:

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...

You’ll help ensure:

• 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

At GBUK, we look for people who share 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.