Medical Device Auditor

🔥 0 minutes ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🔎 Auditor

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SGS

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1878

💼 Consulting

🏥 Healthcare

🍽️ Food & Beverage

Consulting • Healthcare • Food & Beverage

SGS is the world's leading Testing, Inspection, and Certification (TIC) company, providing a comprehensive range of services designed to assure quality and integrity across various sectors. SGS is focused on sustainability, offering climate action services and an all-encompassing ESG portfolio under its IMPACT NOW suite. The company has ambitious targets for growth by 2027, driven by its strategy to address global megatrends. SGS operates globally, providing business assurance, connectivity and products, digital trust, health and nutrition, and solutions for industries and the environment.

📋 Description

• 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