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 of the European Notified Bodies designated for MDR.
Presently, our team is taking care of a global client base who 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.
Key AccountabilitiesSupport with competency approvalAct as a mentor for new Auditors when neededHelp with updating procedures and forms relevant to medical device QMS auditors to improve efficiency and productivityAct as technical managers for all auditors globally and support them with daily queries (technical or operational)Provide and manage training to Medical device auditorsConduct audits at clients in order to maintain competencyComplete specific projects in relation to medical device procedures, processes, systems, and documentation as requested by the Medical Devices ManagerQualificationsPlease 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 AffairsA 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 TechnologyPrevious working experience as Lead Auditor against MDD or MDR within a notified bodyKnowledge ofMedical devices (active, non-active, or software) and Medical device management systemsEU MDD 93/42/EEC (UK MDR 2002), EU MDR 2017/745, EU IVDR 2017/746, ISO 13485Medical Device StandardsIn additionExperience of working under own initiative and in planning and prioritizing workloadsFull driving licenceGood English written and verbal skillsDesirable AttributesRegistered IRCA lead auditor or equivalent registration under other recognized bodyExperience in delivering training and in engaging and working with people at all levels of an organisationPrevious management experiencePrevious training experienceAdditional Information
This position will be hybrid or fully remote depending on the location.
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