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 according to SGS Certification procedures and requirements for ISO 13485, MDSAP, MDD and MDR • Make relevant decisions concerning the audit process and inform SGS when issues fall outside the audit process • Collect and analyze sufficient information to provide a recommendation for certification • Audit clients’ medical device quality systems and technical information against ISO 13485 and other regulatory requirements • Decide whether registration should be recommended or allowed to continue based on audit evidence • Participate in witness audits by SGS or accreditation bodies • Maintain all audit credentials • Adhere to internal standards, policies, and procedures • Travel by automobile and airplane to perform audits, including travel to Canada and Mexico • Travel on weekends when necessary to meet scheduling requirements

🎯 Requirements

• 2+ years of direct sterilization experience, primarily EO and Gamma • 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 quality management systems • Experience with cardiovascular soft tissue implants (MDN1101) and/or general non-active non-implantable healthcare devices (MDN1214) preferred • Experience with ISO 14001, ISO 45001 and/or ISO 50001-based management systems preferred • Auditor credentials for ISO 13485, MDSAP, MDD and/or MDR preferred • Experience with non-active cardiovascular, vascular, and neurovascular implants preferred • Experience with non-active, non-implantable ophthalmologic devices preferred • Sterilization expertise in ETO, irradiation, and moist heat preferred • ISO 9001 qualification preferred • Highest advanced level of English • Excellent verbal, written, presentation, communication, and interpersonal skills • Proactive attitude and excellent organizational skills • Ability to react effectively in stressful situations and make clear, well-founded conformity decisions during audits • Ability to multitask and manage multiple projects while delivering results on time • Integrity, tact, and character • Intermediate user proficiency with MS Office Suite, including Word, Excel, and PowerPoint • Ability to travel up to 80% by automobile and airplane • Must be able to travel to Canada and Mexico • Weekend travel may be necessary

🏖️ Benefits

• Remote work • Equal Opportunity Employer • Reasonable accommodations for qualified individuals with disabilities