Product Assessor - Orthopaedic and Dental
SGS North America Inc.

Columbus, Ohio

This job has expired.


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 Orthopaedic and Dental 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 in the field of healthcare products or related activities, such as in design, manufacturing, auditing or research. You'll also require specific experience within the design, manufacture, testing or use of Orthopaedic medical devices.

Experience of conducting Orthopaedic assessments for another Certification/Notified body (Technical File reviewer) would be advantageous.

In addition the ideal candidate will also bring;

  • Degree or equivalent level qualification linked to 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 knowledge in any of the following;
    • Non-active osteo- and orthopaedic implants (MDN1102)
    • Prosthetic joint replacements (i.e. knee, hip, shoulder, elbow, wrist, ankle, fingers, etc implants)
    • Artificial spinal disc, spinal cages...
    • Bone graft substitute for orthopaedic indications, bone cements, etc
    • Osteosynthesis devices such as orthopaedic nails, screws, plates, etc
APPLY NOW for full consideration, you can be sure that your application will be treated confidentially and impartially, and you will always receive an update within 10 business days.


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