Medical Device Validation Engineer - Quality & Compliance Lead

GBUK Group; Selby; On-site; GBP 45,000 - 60,000; Full time

Job summary

GBUK Group is seeking a Validation Engineer to join the R&D/Quality team at the Head Office in Selby, North Yorkshire. You will lead validation activities across the product lifecycle, ensuring regulatory compliance and high-quality medical devices.

You will collaborate with R&D, Quality, Regulatory Affairs and Manufacturing, producing protocols and reports, reviewing processes, and supporting audits. Relevant ISO standards and a strong documentation focus are essential.

Qualifications

• Knowledge of medical device process validation requirements and ISO 13485.
• Understanding of sterilisation validation standards ISO11135, ISO11737 and ISO10993-7.
• Knowledge of cleanroom standards ISO14644.
• Excellent written documentation skills with attention to detail.
• Ability to manage multiple projects and priorities.
• Strong communication and stakeholder management skills.
• Proficient in Microsoft Office applications.
• Full UK driving licence and access to a vehicle.
• Experience in the medical device industry.
• Around three years' experience in validation within a regulated manufacturing environment.
• Experience in FMCG or another highly regulated manufacturing sector.

Responsibilities

• Plan, coordinate and deliver validation activities for new and existing medical devices.
• Produce, review and approve validation protocols, reports and documentation.
• Review manufacturing processes for compliance with medical device regulations and standards.
• Collaborate with suppliers to obtain validation evidence.
• Support risk management activities and contribute to Risk Management Files.
• Plan validation projects, maintain schedules and hit milestones.
• Coordinate validation studies with external laboratories and partners.
• Support change control and investigations into non-conformances.
• Assist audits and provide training as needed.
• Identify opportunities to improve validation processes and product quality.

Skills

Project management

Stakeholder management

Documentation

Communication

Quality mindset

Education

Engineering or science degree

Tools

Microsoft Office

Job description

GBUK Group is seeking a Validation Engineer to join the R&D/Quality team at the Head Office in Selby, North Yorkshire. You will lead validation activities across the product lifecycle, ensuring regulatory compliance and high-quality medical devices.

You will collaborate with R&D, Quality, Regulatory Affairs and Manufacturing, producing protocols and reports, reviewing processes, and supporting audits. Relevant ISO standards and a strong documentation focus are essential.