Senior Medical Devices Auditor

1 week ago


Mississauga, Ontario, Canada SGS Full time

SGS is the top testing, inspection, and certification company worldwide. At SGS, we are known for our commitment to sustainability, quality, and integrity. With a team of 99,600 employees across 2,600 offices and laboratories, we strive to create a better, safer, and more interconnected world.

Job Description:

  • Perform third-party audits in Canada and the US, and review technical information following SGS Certification procedures and ISO standards.
  • Lead a team of auditors in conducting medical device audits, ensuring compliance with SGS Global/Local procedures.
  • Collect and analyze data to make certification recommendations.
  • Review clients' medical devices quality systems to meet ISO standards and regulatory requirements.
  • Evaluate technical dossiers according to relevant standards and regulations.
  • Provide technical advice to marketing and sales teams and conduct presentations on standards.

Qualifications:

  • Bachelor's Degree in Science or Engineering with at least 10 years of experience in Medical Devices Manufacturing, including 5 years in auditing ISO standards.
  • RAB/QSA or IRCA approved Quality auditing training completion required.
  • Registered Quality Lead Auditor with a background in design engineering or research and development.
  • Global Regulatory Affairs knowledge, FDA experience, and familiarity with Quality Management System auditing standards.
  • Ability to travel extensively in the US with necessary licenses.

Additional Information:

SGS Canada provides equal opportunities and accommodations for candidates with disabilities during the hiring process. We welcome international applicants and offer support for visa and relocation.



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