QMS Lead Auditor manager

Company Description

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 97,000 employees operate a network of 2,650 offices and laboratories, working together to enable a better, safer and more interconnected world.

Job Description

NB1639, part of SGS Belgium NV, is one to the European Notified Bodies designated for MDR. Presently, our team is taking care of a global client base whom are either transferring their products to the new regulation or are bringing their innovative products to the European Market. Our team is comprised of highly competent and skilled staff each playing an important role in bringing safe and efficacious Medical devices to the patient.

We have an excellent opportunity for a QMS Lead Auditor manager to join our global organisation. The successful candidate will be responsible for global technical management of Auditors and Lead Auditors involved in MDD (UK MDR 2002) and MDR onsite audit (often coupled with ISO 13485 enabling the delivery of assessment and certification services in a harmonised approach globally that meet customer and regulatory requirements in accordance with appropriate accreditation requirements.

Key Accountabilities:

Once trained as medical device Lead Auditor the candidate will be accountable for: 

• Recruitment and prescreening candidate’s medical device Auditor globally
• Support with competency approval
• To act as mentor for new Auditors when needed
• To help with update procedure and forms relevant to medical device QMS auditors to improve the efficiency and productivity
• To act as technical managers for all auditors globally and support them with daily queries (technical or operational).
• To provide and manage training to Medical device auditors.
• To Conduct audits at clients in order to maintain competency
• Complete specific projects in relation to medical device procedures, processes, systems and documentation as requested by the Medical Devices Manager.

Qualifications

Please submit your CV in English

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.
• Previous working experience as Lead Auditor against MDD or MDR within a notified body

Knowledge of:

• 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.

In addition:

• Experience of working under own initiative and in planning and prioritizing workloads.  
• Full driving licence.
• Good English written and verbal skills.

The following attributes would be desirable, but not essential:

• Registered IRCA lead auditor, or equivalent registration under other recognized body.
• Experience in delivering training and in engaging and working with people in all levels of an organisation.
• Previous management experience
• Previous training experience

Additional Information

This position will be hybrid or fully remote depending on the location. 

We are interested in hiring candidate based in one of the following location: Ankara, Budapest, London, Amsterdam, Madrid, Rome, Brussels, Paris