Validation Engineer – Medical Devices (Contract)

Randstad; Witney; On-site; GBP 35,000 - 66,000; Full time

Job summary

Randstad is seeking a Validation Quality Engineer for a 12-month initial contract in Witney. You will be embedded with R&D and software teams, ensuring software validation processes meet ISO 13485 / FDA‑regulated requirements and supporting regulatory compliance.

The role involves writing and reviewing validation protocols, participating in change control, and collaborating with QA to support audits and risk assessments.

Qualifications

• Experience working in a strictly regulated environment (medical devices ISO 13485 / FDA 21 CFR Part 820 preferred).
• Proven track record as a Validation Engineer with hands-on validation protocol writing.
• Strong understanding of software validation lifecycles and regulatory requirements.
• Ability to guide software developers and project stakeholders on compliance strategy.

Responsibilities

• Embed within medical device project teams to guide validation processes and compliance pathways.
• Ensure software development teams adhere to software validation lifecycles and regulatory standards.
• Author, review, and execute validation protocols, reports, and documentation to meet quality requirements.
• Lead change control activities and provide expertise on validation changes within QMS procedures.
• Support audits, risk assessments, and continuous improvement initiatives with the QA team.

Skills

Regulated environment experience

Validation protocols

Lifecycle & Change Control

Collaborative communicator

Job description

Randstad is seeking a Validation Quality Engineer for a 12-month initial contract in Witney. You will be embedded with R&D and software teams, ensuring software validation processes meet ISO 13485 / FDA‑regulated requirements and supporting regulatory compliance.

The role involves writing and reviewing validation protocols, participating in change control, and collaborating with QA to support audits and risk assessments.