Senior Medical Devices Auditor
1 week ago
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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