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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in conducting third-party audits for ISO 13485, MDSAP, MDD, and MDR compliance, with a strong focus on medical device quality systems and sterilization processes. Proficient in making conformity decisions and managing multiple audit projects effectively while adhering to internal standards.
Highest-signal resume keywords
ISO 13485 ComplianceMedical Device AuditingSterilization ExpertiseISO 9001 QualificationAdvanced English Proficiency
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
ISO 13485MDSAPMDDMDRMedical Device Quality SystemsSterilization TechniquesAudit Process Decision-MakingTechnical Application of StandardsProject ManagementData Analysis
Soft Skills
MultitaskingClear CommunicationProblem-Solving
Tools & Technologies
MS Office Suite
Certifications & Qualifications
ISO 9001
Industry Keywords
Medical DevicesNon-Active Cardiovascular ImplantsNeurovascular ImplantsOphthalmologic DevicesHealthcare Devices
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Benefits
Comp & perks- 🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account SGS Website LinkedIn All 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. Medical Device Auditor 🔥 1 minute ago 🇺🇸 United States – Remote ⏳ Contract/Temporary 🟡 Mid-level 🟠 Senior 🔎 Auditor 🦅 H1B Visa Sponsor Apply Now Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 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 Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Organic Standards Auditor 🕒 Yesterday QIMA 5001 - 10000 🍽️ Food & Beverage 🏥 Healthcare 💼 Consulting Website LinkedIn All Job Openings Organic Standards Auditor conducting USDA-focused audits for QIMA’s food certification services. Reviewing organic integrity, traceability, corrective actions, and certification compliance across U.S. operators. 🇺🇸 United States – Remote 💰 Private equity on 2025-04 ⏳ Contract/Temporary 🟡 Mid-level 🟠 Senior 🔎 Auditor 🦅 H1B Visa Sponsor Risk Adjustment Coding Auditor 🕒 August 2 TEKsystems 10,000+ employees 💼 Consulting 🎯 Recruiter 🏢 Enterprise Website LinkedIn All Job Openings Remote Risk Adjustment Coding Auditor auditing healthcare compliance codes for accuracy. Supporting risk adjustment programs with expertise in HCC coding and regulatory compliance. 🇺🇸 United States – Remote 💵 $32 - $37 / hour ⏳ Contract/Temporary 🟠 Senior 🔴 Lead 🔎 Auditor Auditor Instructors 🕒 July 31 ISS INTERNATIONAL SpA 51 - 200 💼 Consulting 📦 Logistics 🏭 Manufacturing Website LinkedIn All Job Openings Auditor delivering training courses in quality management systems. Focus on ISO certifications and distance learning. 🇺🇸 United States – Remote ⏳ Contract/Temporary 🟡 Mid-level 🟠 Senior 🔎 Auditor 🗣️🇮🇹 Italian Required Risk Adjustment Coding Auditor 🕒 July 30 TEKsystems 10,000+ employees 💼 Consulting 🎯 Recruiter 🏢 Enterprise Website LinkedIn All Job Openings Risk Adjustment Coding Auditor ensuring accuracy and integrity of coded clinical data across risk adjustment programs. Identifying gaps, mitigating risks, and guiding compliance in coding standards. 🇺🇸 United States – Remote 💵 $32 - $37 / hour ⏳ Contract/Temporary 🟠 Senior 🔴 Lead 🔎 Auditor Accountant, CPA – Per Diem or Per Contract Auditor 🕒 July 30 Wix 1001 - 5000 💼 Consulting 📣 Marketing 💸 Finance Website LinkedIn All Job Openings Accountant/CPA assisting with various audit engagements on a per diem or per contract basis with a focus on high-quality client service. 🇺🇸 United States – Remote ⏳ Contract/Temporary 🟢 Junior 🟡 Mid-level 🔎 Auditor View More Auditor Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates About us Is Remote Rocketship legit? Privacy policy Terms of service Job board SEO course Remote Job Search MasterClass AI Apply Copilot OpenClaw job finder Find jobs using your resume Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs