SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. 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.

At SGS, we have an open corporate and international culture, we offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and we are committed to supporting your development within the company.

• Job Title: IVD Lead Auditor & Product Manager
• Job Type: Permanent
• Hours: 37.5 hours per week
• Job Location: Multiple Location, including London, Birmingham, Manchester, Bristol, Southampton UK, Field based
• Travel: Within UK.  Company car or car allowance provided
• Remuneration: Competitive salary and benefits package

We have an excellent opportunity for an IVD Medical Device Lead Auditor & Product Manager to join our global organisation. The successful candidate will be responsible for planning and conducting audits of IVD medical devices to Directive 98/79/EC equivalent to UK MDR 2002 as amended for UKCA, ISO 13485 and MDSAP, enabling the delivery of assessment and certification services that meet customer and regulatory requirements in accordance with appropriate accreditation requirements.  In addition, as Product Manager you will be a Final Reviewer and Certification decision maker and assist with growing the IVD business.

  Key Accountabilities

• Conduct audits at clients’ sites and remotely, in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
• Work alone or lead audit teams as appropriate, enhance client satisfaction and ensure compliance with standards and regulatory requirements
• Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
• Be a Final Reviewer and Certification decision maker for IVD audits.
• Develop and maintain strategic growth plans for IVD services, working with the Head of Sales and Marketing, Operations managers and Academy Manager to ensure all aspects of the customer journey are covered.
• Support UKCA Medical devices Certification Manager with technical and procedural requirements for IVD UKCA certification to ensure SGS compliance and participate in Regulatory Body audits in relation to IVD to ensure we maintain our Approved Body Status.
• Attend meetings with the Global IVD manager and certification managers from other regulatory schemes which are managed elsewhere in the SGS network.
• Ensure appropriate training is provided to IVD auditors and required competent resources are available to deliver on the scheme requirements.
• Support  SGS Academy by delivering training courses to the public in person virtually as requested.

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

• IVD medical devices and Medical IVD device management systems.
• Directive 98/79/EC equivalent to UK MDR 2002 as amended for UKCA, ISO 13485, MDSAP.
• IVD Medical Device Standards.

In addition:

• Experience of working under own initiative and in planning and prioritising workloads.
• Full driving licence for use in the UK.
• Good English written and verbal skills.

The following attributes would be desirable, but not essential:

• 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.
• Experience of reviewing audit packs.
• Review of technical documentation.

Additional information:

This position is ideally suited to an existing Notified Body IVD Lead Auditor looking to develop their career further by progressing into a more managerial role with less time travelling and auditing at clients’ facilities.

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.

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