Senior Medical Devices Auditor
1 month ago
This 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.
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.
Qualifications
Education: Minimum Bachelor’s Degree in Science or Engineering, or equivalent 10 years’ experience in Medical Devices Manufacturing/Industry with 3 years minimum experiences in quality or regulatory related functions. Minimum 5 years of experience auditing for ISO 13485, MDSAP, MDD, IVD, IVDR, UKCA, and MDR standards. Satisfactory completion of an RAB/QSA or IRCA approved training course in Quality auditing. The course(s) must include an examination, which must be passed to evidence satisfactory completion. Registered (IRCA and/or RAB/QSA) Quality Lead Auditor is a MUST Strong background in either design engineering or research and development Global Regulatory Affairs background, including MDD / IVDD. FDA 510(k) experience Experience in radiation, neurological, soft tissue implant, absorbable products, orthopedic, active therapeutic/diagnostic supplying energy, active administration, animal tissue, and/or combination product devices Have competent working knowledge of nationally recognized Quality Management System auditing standards and procedures. Broad knowledge of engineering and technical applications used in the development of medical devices. Ability to travel (80% -100%) to the US, including a valid driver's license. Extended hours and shift work may be required from time to time.
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