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Senior Medical Devices Auditor - Jobs in Mississauga

Job LocationMississauga
EducationNot Mentioned
SalaryNot Mentioned
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent

Job Description

Job DescriptionThis position performs third party audits in Canada and the US and technical information review per SGS Certification procedures and the requirements of ISO 9001, ISO 13485, ISO 13485 under CMDCAS, MDD, MDSAP, IVDR, UKCA and/or JPAL.The Sr. Medical Device Auditor is responsible to make relevant decisions concerning the audit process and to inform SGS as required to resolve issues outside the audit process. The Sr. Medical Device Auditor is responsible to collect and analyze sufficient information to provide a recommendation for certification.The Sr. Medical Device Auditor has the authority for the control and performance of auditing activities including planning and the control of other members of audit teams.

  • Lead Auditors have authority for the control and performance of auditing activities including planning and the control of other members of audit teams.
  • Lead a team of auditors in performing medical device audits, in conformance with the SGS Global/Local procedures
  • This position is responsible to collect and analyze sufficient information to provide a recommendation for certification.
  • Access and review North American clients’ medical devices quality systems and technical information to the requirements of ISO 9001, ISO 13485 and other regulatory requirements for access into Canada, EU, and Japan. Review technical dossiers to the requirements of 93/42/EEC (MDD) and/or 98/79/EC (IVDD).
  • Decide upon evidence gained during audits whether or not manufacturers are in compliance with all relevant standards / regulations, and if registration should be recommended or allowed to continue.
  • Provide technical advice to marketing and sales functions, as required. Utilize and maintain professional communication and presentation skills while meeting with clients.
  • Conduct public presentations / seminars on specific standards, where required.

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