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 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.Job Description
As the Sr. Medical Device Auditor, you will perform third-party audits per SGS Certification procedures and the requirements for ISO 13485, MDSAP, MDD and MDR standards. The Sr. Medical Device Auditor is responsible to make relevant decisions concerning the audit process and to inform SGS SSC as required to resolve issues outside the audit process. The Sr. Medical Device Auditor is responsible to collect and analyze sufficient information to provide a recommendation for certification. The Sr. Medical Device Auditor has the authority for the control and performance of auditing activities including planning and the control of other members of audit teams.
- Perform audits for clients’ medical devices quality systems and technical information to the requirements of ISO 13485 and other regulatory requirements such as MDSAP, MDD, MDR and EU.
- In performing the duties described above, to ensure that such duties are performed in an efficient and commercially expedient way.
- To control as necessary, teams of auditors during the activities covered by items above.
- Decide upon evidence gained during audits whether or not registration should be recommended or allowed to continue.
- Strive to acquire sufficient audit experience to cover the whole of SGS’s Certification's accredited activities.
- 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.
- Maintain all audit credentials.
- Undertake any other activities as directed by the Operations and/or Accreditation Manager.
- As a Lead assessor you are responsible for the overall audit team. The team could be one person or 15 people depending on the assignment.
- Adheres to internal standards, policies and procedures.
- Performs other duties as assigned.
- Bachelor’s degree in a related discipline (i.e., Engineering, Bioscience etc.) AND
- Minimum 5 years of experience auditing for ISO 13485, MDSAP, MDD and MDR standards.
SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.
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, skills, and/or abilities 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.
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Medical Device Directive
Medical Device Reporting