Senior Product Assessor - Madrid, España - SGS

SGS

Empresa verificada

Madrid, España

hace 2 semanas

Publicado por:

Isabel García

beBee Recruiter

Descripción

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
99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

Are you ready to
take your career to the next level? If you have a strong background as a
Product Assessor within an EU
notified body conducting MDD/MDR technical documentation review, then we have an
exhilarating opportunity for you

Join our
dynamic team at SGS and become a
Senior Product Assessor - Active Devices. This role will allow you to make a
significant impact in the field of
certification.

As a member of our
Medical Device team, you will not only
manage a small team of globally based
Product Assessors but also
dive deep into the exciting world of
Active Medical Devices.

Your responsibilities will include:

Supporting and guiding your team of talented
Product Assessors:
Conducting thorough technical documentation reviews and ensuring
compliance with EU regulations and standards

Collaborating with
crossfunctional teams to increase
efficiency and quality:
Monitoring the team's
technical competence, KPIs, and wellbeing and providing feedback and support when there are concerns.
Conduct
recruitment, including reviewing CVs and undertaking interviews and supporting with
onboarding of new starters:
Develop
training and present the training to others in SGS or externally as deemed necessary.
Assist with
technical queries and those related to
sales within the Active Medical Devices field.
Ensure that the
highest level of service is provided throughout the SGS network offering medical devices
certification and stakeholders through
efficient service delivery.

Qualifications

To be eligible for this role, you should have prior experience as a
Product Assessor/Specialist/Technical File Reviewer within another
Notified Body for active devices, conducting reviews
against MDD and/or MDR.

Additionally, you must possess:

Four years of
professional experience in the field of
healthcare products or related activities, such as 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;

-
Active Medical Devices knowledge (monitoring equipment, therapeutic devices, devices utilizing radiation, stand-alone software devices, etc.) through designing, manufacturing, or testing of such devices;

Thorough knowledge and understanding of related
standards: EN 60601, EN 62304, EN 62366, etc.;
Good written
English skills (as reports will be reviewed/queried in English); Knowledge of the following
Technical File codes desirable (as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017)
:MDA0201, MDA0202, MDA0203, MDA0204, MDA0301, MDA0302, MDA0303, MDA0304, MDA0305, MDA0306, MDA0307, MDA0308, MDA0309, MDA0310, MDA0311, MDA0312, MDA0313, MDA0314, MDA0315, MDA0316, MDA0317, and MDA0318.

Additional Information Why SGS?**- Join a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry.

Enjoy a flexible schedule and remote work model.
Access SGS University and Campus for continuous learning options.
Thrive in a multinational environment, collaborating with colleagues from multiple continents.
Benefit from our comprehensive benefits platform.