SGS Australia and Fulcrum Robotics are seeking Contract Medical Device Auditors to perform third-party audits of medical device quality systems. The role involves assessing compliance with key standards including ISO 13485, MDSAP, MDD, and MDR, and making certification recommendations based on audit findings.
What You'll Do
- Perform third-party audits per SGS Certification procedures and regulatory requirements including ISO 13485, MDSAP, MDD, and MDR
- Collect and analyze sufficient information to provide a recommendation for certification
- Make relevant decisions concerning the audit process and inform SGS as required to resolve issues outside the audit process
- 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
What We're Looking For
- ISO 9001 qualification
Nice to Have
- Non-active cardiovascular, vascular, and neurovascular implants (2+ years)
- Non-active, non-implantable ophthalmologic devices (2+ years)
- Sterilization experts (EtO, Irradiation, Moist Heat)
