Internal Auditing Engineer – ISO19001 – Medical Equipment

About the role

We are seeking an Internal Auditing Engineer with expertise in ISO19001 and medical‑device compliance to join a market‑leading company in Cheltenham. You will be the technical authority for legislative compliance and product safety, ensuring that all equipment meets the required standards.

Key responsibilities

• Lead compliance activities for new and existing medical equipment, including testing and documentation.
• Maintain and update the product approval database, ensuring certifications are current.
• Perform inspections and audits to satisfy global safety requirements such as IEC60601‑1.
• Collaborate with design teams to embed compliance considerations early in product development.
• Provide training and guidance to internal teams on regulatory requirements.

Required profile

• Proven experience as an Internal Auditing Engineer or similar role within medical‑device testing.
• Strong understanding of schematic diagrams and product documentation.
• Ability to work autonomously and lead cross‑functional teams.

Required skills

• ISO9001, ISO13485, ISO14971 standards.
• IEC60601‑1 testing and compliance.
• Knowledge of Class I medical device regulations, MDD and MDR.

What we offer

• Competitive salary up to £55,000 per year.
• Career progression and in‑house training.
• Pension scheme and additional company benefits.