We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 98,000employees operate a network of 2,650 offices and laboratories, working together to enable a better, safer and more interconnected world.

We present an exciting opening for a QMS Lead Auditor Manager to become part of our global organization. In this position, the selected candidate will be responsible for supervising the worldwide technical management of Auditors and Lead Auditors involved in MDD (UK MDR 2002) and MDR onsite audits, frequently integrated with ISO 13485.

This involvement ensures the delivery of assessment and certification services in a harmonized approach worldwide, meeting both customer and regulatory requirements and aligning with appropriate accreditation standards.

Key Responsibilities:

Upon completion of training as a medical device Lead Auditor, the candidate will be responsible for:

• Globally recruiting and prescreening candidates for medical device Auditor positions.
• Providing support for competency approval processes.
• Serving as a mentor for new Auditors when required.
• Collaborating on the updating of procedures and forms relevant to medical device QMS auditors to enhance efficiency and productivity.
• Functioning as a technical manager for all auditors worldwide, offering support for daily queries, whether technical or operational.
• Delivering and managing training programs for Medical device auditors.
• Conducting audits at client sites to maintain competency.
• Undertaking specific projects related to medical device procedures, processes, systems, and documentation, as assigned by the Medical Devices Manager.

• A minimum of 4 years of practical experience in designing, manufacturing, or testing medical devices, with 2 years within a formal Quality Management System or in Quality Management/Regulatory Affairs.
• University degree or equivalent qualification in relevant sciences such as Chemistry, Biochemistry, Biology, Microbiology, Biotechnology, Physics, Biophysics, Material Science, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Electronic Engineering, Computer & Software Technology.
• 3 years of prior experience as a Lead Auditor against MDD or MDR within a notified body.
• Demonstrated experience working independently, planning, and prioritizing workloads.
• Possession of a full driving license.
• Proficient in written and verbal English.

Knowledge in:

• Medical devices (active, non-active, or software) and Medical device management systems.
• EU MDD 93/42/EEC (UK MDR 2002), EU MDR 2017/745, EU IVDR 2017/746, ISO 13485.
• Medical Device Standards.

Desirable, but not essential attributes:

• Registered IRCA lead auditor or equivalent registration under other recognized bodies.
• Experience in delivering training and engaging with individuals at all levels of an organization.
• Previous management and training experience.

Why SGS?

• Join a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry.
• Enjoy a flexible schedule and a hybrid/remote work model.
• Access SGS University and Campus for continuous learning options.
• Thrive in a multinational environment, collaborating with colleagues from multiple continents.
• Benefit from our comprehensive benefits platform.

Join Us: At SGS, we are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise, and fulfill your potential. Apply now to be part of our motivated and dynamic team!