Internal Auditing Engineer, ISO; Medical Equipment

Internal Auditing Engineer, ISO
19001 (Medical Equipment)

Cheltenham, England

Up to £55,000 + Career Progression + In-house Training + Pension + Company Benefits

Are you a dedicated Internal Auditing Engineer or similar with a background in Medical Product Testing or similar, seeking an exciting opportunity to work for a market leading company who are passionate about what they do, while offering multiple pathways for development and career progression?

This company specialises in accessibility solutions. Known for its innovative technologies, it develops high-performance products designed to address the specific requirements of various situations and individuals. The organization promotes a collaborative work culture that encourages continuous improvement and employee development.

In this role, you will oversee all aspects of legislative compliance and product safety, ensuring that all products meet relevant standards through rigorous testing and documentation. You will maintain a comprehensive compliance database, participate in product design for certification, and conduct training to uphold compliance across the organization through leading department teams to ensure the best standards.

• Act as the technical authority on legislative compliance and product safety.
• Conduct detailed testing on new and existing products, generating reports for documentation.
• Maintain and update product approvals and certifications in line with current standards.
• Perform inspections to meet global safety requirements for product certification.
• Collaborate in the design of new products to ensure compliance.

• Internal Auditing Engineer or similar.
• Proficient in understanding schematic diagram.
• Strong documentation and reporting skills.
• Knowledge of regulatory requirements for Class I medical devices to MDD and MDR.
• Experience and competence complying to ISO 9001, ISO 13485, ISO 14971.
• Experience testing and complying to IEC standards.
• Reference: BBBH
  25446.

We are an equal opportunities employer and welcome applications from all suitable candidates. The salary advertised is a guideline for this position. The offered remuneration will be dependent on the extent of your experience, qualifications, and skill set.