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Medical Device Auditor

📁
Certification
📅
049157 Requisition #

SGS is the world’s largest inspection, verification, testing and certification company. We provide clients with a global network of medical device offices, laboratories and experts. Operating in over 35 countries, SGS offers tailored global and local solutions to meet your certification, testing, training and audit requirements.



**This position can be located anywhere in the United States**



SUMMARY

The SGS Medical Device Auditor performs third party audits and technical information reviews per SGS Certification procedures and the requirements of ISO 9001 and ISO 13485 under MDSAP, MDD and IVDD. The Medical Device Auditor is responsible for collecting and analyzing information to provide a recommendation for medical device certification. The Auditor will make decisions concerning the audit process and inform SGS as required to resolve issues outside the audit process.

 
RESPONSIBILITIES
  • Perform audits as an auditor or lead auditor, 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 such as MDSAP, EU.
  • Decide upon evidence gained during audits whether manufacturers meet the requirements of relevant standards / regulations, and if registration should be recommended. 
  • Respond to client inquiries on all technical matters regarding SGS-SSC certification / training products. 
  • Provide technical advice to those marketing and sales functions as required.
  • Report any customer complaints, problems and or system deficiencies to the Director of Healthcare and Certification Management. 
  • Maintain competence and audit credentials by taking additional and/or refresher course(s), as necessary. 
  • 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. 
  • Undertake any other activities as directed by the Director of Healthcare and/or Accreditation Manager. 
REQUIREMENTS
  • Bachelor’s degree in Science, Engineering or a related field.
  • Minimum 5 years of recent and relevant medical industrial experience or business experience.
  • Possess an auditor certificate from a recognized organization is a plus
  • Possess experience with medical device products in one or more of the following areas: radiation, neurological, soft tissue implant, absorbable products, orthopaedic, active therapeutic/diagnostic supplying energy, active administration, animal tissue etc.
  • Strong background and knowledge of engineering and technical applications used in the development of medical devices.
  • Global Regulatory Affairs background, including MDD / IVDD. 
  • Experience in FDA 510(k).
  • Proactive attitude and excellent organizational skills.
  • Effectively react in stressful situations and make clear, well-founded decisions regarding conformity during the audit.
  • Ability to multitask and manage multiple projects while delivering results on time.
  • Excellent interpersonal, verbal, written and presentation skills 
  • Ability to travel, including a valid driver's license 
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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