Medical Device Auditor
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Job Description
Contract medical device auditor conducting ISO 13485, MDSAP, MDD, and MDR audits for SGS certification. Evaluating quality systems and recommending certification based on audit evidence.
Responsibilities:
- Perform third-party audits per SGS Certification procedures and requirements for ISO 13485, MDSAP, MDD, and MDR
- Make relevant decisions concerning the audit process and inform SGS to resolve issues outside the audit process
- Collect and analyze sufficient information to provide a recommendation for certification
- Perform audits for clients’ medical device quality systems and technical information
- Decide whether registration should be recommended or allowed to continue based on audit evidence
- Participate actively in witness audits by SGS or accreditation bodies
- Maintain all audit credentials
- Adhere to internal standards, policies, and procedures
- Travel up to 80% by automobile and airplane, with possible weekend travel
Requirements:
- Bachelor’s degree in a related discipline such as Engineering, Bioscience, Biomedical, or Science
- Minimum 4 years of experience working with medical devices under ISO 13485, MDSAP, MDD and/or MDR-compliant QMS
- Experience with non-active cardiovascular, vascular, and neurovascular implants for 2+ years
- Experience with non-active, non-implantable ophthalmologic devices for 2+ years
- Experience with general non-active, non-implantable healthcare devices for 2+ years
- Sterilization expertise, primarily EtO, irradiation, and moist heat
- ISO 9001 qualification
- Highest advanced level of English; Spanish preferred
- Strong knowledge of technical applications of the standards
- Intermediate proficiency with MS Office Suite (Word, Excel, PowerPoint)
- Ability to travel up to 80% by automobile and airplane, including possible weekend travel
- Ability to make clear, well-founded conformity decisions during audits
- Ability to multitask and manage multiple projects while delivering results on time
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