Qms Lead Auditor Manager

6 mesi fa

Roma, Italia SGS A tempo pieno

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 98,000employees operate a network of 2,650 offices and laboratories, working together to enable a better, safer and more interconnected world.

**Job Description**:
**Key Accountabilities**:

- 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 CV in English.

**Essentials**:
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.
- 3 years 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.

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