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 standards including 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 of clients’ medical device quality systems and technical information against ISO 13485 and regulatory requirements such as MDSAP, MDD, MDR and EU requirements • Determine from audit evidence whether registration should be recommended or allowed to continue • Participate 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 • Travel to Canada and Mexico to perform audits • Travel on weekends when necessary to meet scheduling requirements

🎯 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 quality management systems • 2+ years of direct sterilization experience, primarily EO and Gamma, required • 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 one or more of ISO 13485, MDSAP, MDD and 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 • Strong background and knowledge of technical applications of the standards • Highest advanced level of English • Excellent communication, interpersonal, verbal, written, and presentation 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 • Act with integrity, tact, and character • Intermediate proficiency with MS Office Suite, including Word, Excel, and PowerPoint • Must be authorized to travel to and provide auditing services in the United States, Canada, and Mexico • Ability to travel up to 80% by automobile and airplane • Weekend travel may be necessary

🏖️ Benefits

• Employees can work remotely • Contract opportunity • Travel reimbursement or arrangements are not explicitly stated • Equal Opportunity Employer • Reasonable accommodations available