We are looking for Contract Medical Device Auditors with the following preferred experience:
- Non-active cardiovascular, vascular, and neurovascular implants (2+ years)
- Non-active, non-implantable ophthalmologic devices (2+ years)
- Sterilization experts (EtO, Irradiation, Moist Heat)
- ISO 9001 qualification
As a Contract Medical Device Auditor, you will perform third-party audits per SGS Certification procedures and the requirements for standards such as ISO 13485, MDSAP, MDD and MDR. You will be responsible for making relevant decisions concerning the audit process and to inform SGS as required to resolve issues outside the audit process. The Contract Medical Device Auditor is responsible for collecting and analyzing sufficient information to provide a recommendation for certification.
- Perform audits for clients’ medical device quality systems and technical information to the requirements of ISO 13485 and other regulatory requirements such as MDSAP, MDD, MDR and EU.
- Decide upon evidence gained during audits whether or not registration should be recommended or allowed to continue.
- Participate actively in witness audits by SGS or accreditation bodies.
- Maintain all audit credentials.
- Adheres to internal standards, policies, and procedures