Product Assessor

4 weeks ago


Mississauga, Ontario, Canada SGS Full time
Job Overview

SGS is seeking a highly skilled Product Assessor to join our team in the Global Medical Device office (MDO). As a Product Assessor, you will play a critical role in ensuring the highest level of service is provided through efficient service delivery and meeting customer requirements while adhering to SGS Policies, procedures, and processes.

Key Responsibilities
  • Conduct technical file reviews of Class 11a/11b and/or Class III and approve or raise queries based on technical and procedural knowledge.
  • Ensure reviews are technically sound and in compliance with all applicable regulations, standards, guidelines, and competent authority expectations.
  • Project manage reviews as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards.
  • Maintain personal competence and development in qualified specialist areas on an ongoing basis.
  • Support/assist on queries raised from the review.
  • Work at all times to adhere to KPI's set as an individual and within a team.
Requirements
  • Bachelor's degree in a related discipline (medicine, pharmacy, engineering, or other relevant sciences).
  • Minimum 4 years of experience in the field of healthcare products or related industry (manufacturing, auditing, or research).
  • Active Medical Devices knowledge: stand-alone software devices, etc. through designing, manufacturing, or testing of such devices.
  • Minimum 2 years in the design, manufacture, testing, or use of the device or technology to be assessed or related to the scientific aspects to be assessed.
  • A broad range of codes and previous Technical File review experience.
  • Ability to travel across Canada and the US (Up to 50%).

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