Medical Devices Lead Auditor
hace 3 semanas
Medical Devices Lead Auditor & Training Specialist
Main ResponsibilitiesWe are seeking a Medical Devices Lead Auditor & Training Specialist to join our team at SGS. The successful candidate will report directly to the Global Medical Devices Technical Training Manager and have dual responsibilities as Lead Auditor and Auditor Training Specialist.
Lead Auditor Responsibilities- To develop and deliver auditor training materials for the global business scope.
- To evaluate and approve trainee auditors L1 audits.
- To ensure auditor qualifications remain in place, support planning and conduct management system audits in accordance with SGS procedures to enable delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.
- To be a key expert of contact and mentor to colleagues and play a key role in the qualification of new auditors.
- In line with personnel management procedures, help prepare, deliver and assess training and integration aspects of the qualification process.
- To support the development of the global SGS medical device auditor network by aiding the qualification of trainee auditors.
- To act as a key point of contact for the SGS medical device offices, a mentor for junior colleagues and help coordinate the expansion of the IVDR auditor network.
- To contribute to the continuous improvement of processes and tools used across the SGS network to conduct MDR/IVDR conformity assessment.
- To maintain own auditor competences.
We are looking for someone with:
- Full knowledge of EU MDR 2017/745.
- Previous auditing experience within an MDR notified body is mandatory.
- 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.
- General expertise including but not limited to risk management (ISO 14971), usability, biocompatibility, clinical standards and guidance documents relevant to medical devices.
- Meet the prerequisite per LPMDREG7001 for MDR and/or LPIVDREG7106 for IVDR.
- Demonstrate 2 years working knowledge on MDN/MDA/MDS codes for MDR.
- Good English written and verbal skills.
- Experience of working under own initiative and in planning and prioritising workloads.
- Willingness to travel internationally as required (60% of time).
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