Product Assessor - Sterilisation
SGS North America Inc.

Job Info

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Company Description

SGS is the world's leading inspection, verification, testing and certification company. We are recognized as the global benchmark for quality and integrity. With more than 95,000 employees, we operate a network of more than 2,400 offices and laboratories around the world.

We aim to be the most competitive and the most productive service organization in the world. Our core competencies in inspection, verification, testing and certification are being continuously improved to be best-in-class. They are at the heart of what we are.

Job Description

As a Product Assessor you'll be responsible for conducting Sterilisation product assessments and technical file reviews in compliance with all applicable requirements including the European Medical Device Directive and Medical Device Regulation for Class IIa /IIb and/or Class III. You'll ensure that reviews are technically sound and in compliance with all applicable requirements.

You'll also support CE marking activities carried out by SGS, support in training and qualification of more junior staff, and create training materials.

You'll communicate with team members and client with regards to the product assessment or other activities performed and work to minimise risks associated with medical device certification.

Qualifications

The successful candidate will bring extensive experience within medical device manufacturing. You'll have experience and knowledge in the operation of the relevant sterilization processes (ETO, Irradiation, Steam, Aseptic etc.), clean room controls, including validation of the considered process for which they wish to be qualified.

Experience of conducting sterilisation Product Assessments for another Certification/Notified body (Sterilisation-Technical File reviewer) would be advantageous.

In addition the ideal candidate will also bring;

• A degree or equivalent qualification which includes Microbiology modules or relevant studies e.g. medicine, pharmacy, engineering or other relevant sciences
• Good communication techniques through electronic mediums
• Good written English skills (as reports will be reviewed/queried in English)
• Medical device/ procedure packs Sterilisation process knowledge is required in following methods-
  • (MDS1005/ MDS1011)
  • ETO Sterilization
    • Irradiation Sterilization
    • Steam (and dry) Sterilization
    • Aseptic Sterilization
  • any additional knowledge will be advantageous i.e.
    • Hydrogen Peroxide (gas plasma)
    • Any other sterilization methods for Medical devices
• Non-active, non-implantable devices for disinfection, cleaning and rinsing (MDN1211)
• Solutions for disinfecting medical devices, contact lens care, catheter lock solutions
• Devices manufactured in clean rooms and associated controlled environments (MDT2008)

This job has expired.