We are delighted that you're thinking about a career with SGS!

We currently have an exciting opportunity at SGS for a Medical Device Auditor to join our highly successful certification division in the South Region of the UK. 

SGS are the global leader and innovator in inspection, verification, testing and certification services. Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.

• Job Title: Medical Device Lead Auditor  - Non active, Sterile 
• Job Type: Permanent
• Hours: 37.5 hours per week
• Job Location: Field-based (UK - South)
• Travel: Within the UK,  a Company car or car allowance provided
• Salary: From £65,000

At SGS, we believe in rewarding our employees for their hard work and commitment. As part of our team, you would be eligible for:

• Retention bonus scheme (Bonus rises each year of employment)
• Private medical cover (subject to eligibility criteria)
• Competitive pension scheme + Life Assurance
• Generous Annual Leave allowance (increasing with service) plus bank holidays.

The successful candidate will be responsible primarily for planning and conducting audits of sterile medical devices. The role will include auditing to EU and UK Medical Device Regulations and ISO 13485 Quality Management System Standard enabling the delivery of assessment and certification services that meet customer, regulatory and accreditation requirements. We are looking for candidate who are currently approved as a Medical Device Regulatory Lead auditor. 

We will also provide full training to candidates with suitable knowledge and ‘hands-on’ experience in design and manufacture of medical devices, including different sterilisation techniques e.g. Radiation per ISO 11137, Ethylene Oxide per ISO 11135, Moist Heat per ISO 17665 or Aseptic Processing per ISO 13408. Training to enable qualification under all schemes will be provided.

Key Accountabilities:

• Conduct audits at customers’ sites and remotely, by using established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
• Work alone or lead audit teams as appropriate, enhance customer satisfaction and ,ensure compliance with standards and regulatory requirements.
• Complete all work within the required budget and timeframes
• Complete specific projects about medical device procedures, processes, systems and documentation as requested by the Medical Devices Manager.

A minimum of 4 years ‘hands-on’ professional experience of designing, manufacturing or testing medical devices:

• 2 years of the 4 years from working within a formal Quality Management System or working in Quality Management /Regulatory Affairs.
• A university degree or equivalent qualification in relevant sciences such as: Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Physics, Biophysics, Material Science Biomedical Engineering,  Mechanical, Electrical or Electronic Engineering, Computer & Software Technology.

Knowledge of:

• Medical device regulations and Medical device quality management systems.
• Medical Device and Sterilisation Standards.

In addition:

• Experience of working under own initiative and in planning and prioritising workloads.  
• Full driving licence for use in the UK.
• Willingness to travel nationally and internationally as and when required 

The following attributes would be desirable, but not essential:

• Knowledge of MDSAP.
• Registered IRCA lead auditor, or equivalent registration under other recognised body.
• Experience in delivering training and in engaging and working with people in all levels of an organisation.

APPLY NOW for full consideration, you can be sure that your application will be treated confidentially and impartially, and you will always receive an update within 10 business days.