Qms Lead Auditor Manager

2 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**:
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.

**Main Purpose of Role**
- To conduct technical file reviews against European Medical Device Directive and Medical Device Regulation for Class I/ IIa /IIb and/or Class III within the defined timeframe
- To conduct technical file reviews against In Vitro Diagnostic Medical Device Regulation for Class B and Class C devices within the defined timeframe
- Support CE marking activities carried out by SGS including support of sales, Contracts approval or scheduling team with technical queries
- Ensure that reviews are technically sound and in compliance with all applicable requirements
- Support in training and qualification of colleague and create training materials
- Ensure adherence to SGS policies, procedures, and processes
- Communication with team members and client with regards to the product assessment or other activities performed
- Minimise risks associated with medical device certification

**Key Accountabilities**
- Ensure regulatory compliance of product technical file assessment under applicable EU Medical Devices Directives and /or Regulations
- Conduct product assessments (primarily desk-based) in accordance with established procedures, maintaining a high standard of service delivery
- Maintain personal competence and development in qualified specialist areas to be able to assess product technical documentation on an ongoing basis.
- Project manage assessments as appropriate, to maximize efficiencies, enhance client satisfaction, and ensure compliance with requirements
- To assist with queries raised from product assessments
- Work at all times to adhere to KPIs set as an individual and within a team
- Ensure that the highest level of service is provided throughout the SGS network offering medical devices certification and stakeholders through efficient service delivery
- Ensure full compliance with the Company’s Code of Integrity & Professional Conduct, and act in accordance with SGS policies.
- At all times, adopt a safe behavior by exercising due regard for the health and safety of yourself, colleagues and clients, in line with the Company’s policies and procedures.

**Qualifications**:
Please submit your CV in English.

**Experience**

Essential
- Four years professional experience in the field of healthcare products within clinical setting such as clinical biochemist/ scientist or within manufacturing related activities, such as in design, manufacturing, auditing or research, of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed.

Desirable
- Broad range of competency codes and previous technical file review experience within Notified Body against IVDR or IVDD or MDD and MDR

**Skills & Knowledge**

Essential
- Medical device knowledge on MDA/MDN/MDS codes for MDR
- and/or IVDR/IVS/IVP/IVD codes for IVDR listed in Commission implementing regulation (EU) 2017/2185
- Good communication techniques through electronic mediums
- Good written English skills (as reports will be reviewed/queried in English)

Desirable
- Experience with the following technologies and devices would be particularly advantageous:

- Determination of risk or prognosis of genetic / inherited disorders (IVR 0402, IVR 0403)
- Histocompatibility, immunogenetics, immunohistochemistry and/or histology (IVD 4006, IVD 4007)
- Devices for the detection of non-conventional transmissible agents (CJD, vCJD) (IVD 4003)
- Devices for pre-natal screening of women for their immune status towards infectious agents (IVR 0501)
- Devices for screening of human organs, tissues, blood, etc. For presence of transmissible agents (IVR 0502)- Active Medical Devices (MDA codes), and Ophthalmic devices (Active or non active)
- Experience of working to KPIs
- Experience of planning own workload/priorities
- Ability to work with online systems
- Previous Technical File assessments

**Qualifications**

Essential
- Successful completion of a university or technical college degree or equivalent qualification in relevant studies e.g. medicine, pharmacy, engineering or other relevant sciences

Desirable
- Product Assessment for another Certification/Notified body

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