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Lead Medical Device Auditor

SGS is the world?s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 85,000 employees, SGS operates a network of more than 1,800 offices and laboratories around the world.



Job Summary:


The successful candidate will perform third-party audits and technical information review in accordance with SGS?s Certification procedures and the requirements of ISO 9001, ISO 13485, ISO 13485 under CMDCAS, MDD, IVDD, and/or JPAL. In addition, the successful candidate will:



Specific Responsibilities:



  • Make relevant decisions concerning the audit process and for informing SGS to resolve issues outside the audit process.?

  • Collect and analyze sufficient information to provide a recommendation for certification, with authority over the control and performance of auditing activities.?

  • Lead a team of auditors in performing medical device audits, in conformance with the SGS Global/Local procedures.?

  • 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, European Union (?EU?), Japan, and review technical dossiers to the requirements of 93/42/EEC (MDD) and/or 98/79/EC (IVDD).?

  • Determine (upon evidence gained during audits) whether or not manufacturers are in compliance with all relevant standards/regulations, and whether registration should be recommended or allowed to continue.

  • Present SSC Standard Training Courses and, upon approval, deliver such courses in a tutoring role.?

  • Provide technical advice to marketing and sales functions, as required. Utilize and maintain professional communication and presentation skills while meeting with clients.?

  • Respond to client inquiries on all technical matters regarding SGS-SSC certification/training products.?

  • Report customer complaints, problems and/or system deficiencies to the Director of Healthcare and Certification Management.?

  • Assist in the training of other auditors and lead auditors during planned audits or during other training functions.?

  • Participate actively in witness audits by SGS or accreditation bodies.?




Education and Required Skills:

  • Must have a Master?s degree in Biomedical Engineering or a related field plus 3 years of experience in the job offered or related occupation, or a relevant Bachelor?s degree plus 5 years of relevant progressive experience.?

  • Must have 3-5 years of experience (depending on degree) with engineering and technical applications used in the development of medical devices; 3-5 years (depending on degree) of recent and relevant medical industrial or business experience within the medical device manufacturing industry and/or medical device certification industry; solid understanding of Global Regulatory Affairs, including the European Medical Device Directive (MDD); and competent working knowledge of nationally recognized Quality Management System auditing standards and procedures.?

  • May work from home anywhere in the U.S.


ADDITIONAL INFORMATION:



  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skill, and/or ability required. This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company?s rights to assign or reassign duties and responsibilities to this job at any time.?


SGS is an EOE AA M/F/Vet/Disability employer.
Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, protected veteran status or disability.
If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will be called back shortly. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.







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