SGS Australia / Fulcrum Robotics is hiring Contract Medical Device Auditors to perform independent third-party audits. You will ensure client compliance with standards like ISO 13485, MDSAP, MDD, and MDR, making critical decisions on certification recommendations. This role requires adhering to SGS certification procedures and maintaining high professional standards.
What You'll Do
- Perform third-party audits per SGS Certification procedures and standards such as ISO 13485, MDSAP, MDD, and MDR.
- Make audit process decisions and escalate issues to SGS as needed.
- Collect and analyze information to provide recommendations for certification.
- Audit clients' medical device quality systems and technical information against relevant standards.
- Determine whether registration should be recommended or continued based on audit evidence.
- Participate in witness audits conducted by SGS or accreditation bodies.
- Maintain all required audit credentials.
- Adhere to internal standards, policies, and procedures.
What We're Looking For
- Bachelor’s degree in Engineering, Bioscience, Biomedical, Science, or a related discipline.
- Minimum 4 years of experience working with medical devices under an ISO 13485, MDSAP, MDD, and/or MDR compliant QMS.
- Highest advanced level of English proficiency.
- Excellent communication, interpersonal, verbal, written, and presentation skills.
- Proactive attitude and excellent organizational skills.
- Ability to perform effectively in stressful situations and make clear, well-founded conformity decisions.
- Ability to multitask and manage multiple projects while delivering results on time.
- High integrity, tact, and character.
- Ability to travel to both the US and Canada.
- Willingness to travel up to 80% of the time (automobile & airplane), with potential weekend travel.
Nice to Have
- Auditor Credentials for one or more of these standards: ISO 13485, MDSAP, MDD, MDR.
- Experience with Non-active cardiovascular, vascular, and neurovascular implants (2+ years).
- Experience with Non-active, non-implantable ophthalmologic devices (2+ years).
- Experience as a Sterilization expert (EtO, Irradiation, Moist Heat).
- ISO 9001 qualification.
- Strong background and knowledge of technical applications of the standards.
Technical Stack
- MS Office Suite (Word, Excel, PowerPoint) – Intermediate user proficiency.
Work Mode
This is a local-country contract position. You must be located and authorized to work in the US or Canada.
SGS is an Equal Opportunity Employer, recruiting, hiring, training, and promoting 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.
