Medical Device Validation Engineer – Quality & Compliance

GBUK; Selby; On-site; GBP 45,000 - 65,000; Full time

Job summary

GBUK is seeking a Validation Engineer to join our Head Office team in Selby, North Yorkshire. You will lead validation activities across the product lifecycle to ensure high standards of quality, safety and regulatory compliance in our medical devices.

The role collaborates across R&D, Quality, Regulatory Affairs and Manufacturing to deliver robust validation studies. We value strong technical knowledge, excellent organisation and communication, and a drive to improve validation processes and

Qualifications

• Experience in validation within a regulated manufacturing environment.
• Knowledge of ISO 13485 and related quality management systems.
• Familiarity with sterilisation validation standards (ISO 11135, ISO 11737, ISO 10993-7).
• Strong documentation and record-keeping abilities.
• Experience coordinating multiple validation projects and stakeholders.

Responsibilities

• Produce, review and approve validation protocols, reports and associated technical documentation.
• Review manufacturing processes and documentation to ensure regulatory compliance.
• Coordinate validation projects and maintain validation schedules.
• Collaborate with suppliers and external laboratories for validation evidence.
• Support risk management, change control activities and investigations into non-conformances.
• Assist with audits and provide training to colleagues.
• Identify improvements to validation processes and product quality.
• Escalate product quality or patient safety concerns when needed.

Skills

Validation experience

ISO 13485 knowledge

Risk management

Regulatory compliance

Documentation

Project coordination

Stakeholder management

MS Office

Education

Engineering, Science or related technical degree

Tools

MS Office

Job description

GBUK is seeking a Validation Engineer to join our Head Office team in Selby, North Yorkshire. You will lead validation activities across the product lifecycle to ensure high standards of quality, safety and regulatory compliance in our medical devices.

The role collaborates across R&D, Quality, Regulatory Affairs and Manufacturing to deliver robust validation studies. We value strong technical knowledge, excellent organisation and communication, and a drive to improve validation processes and