Remote Medical Device Auditor - Lead ISO 13485 & MDSAP
Intertek CEA
- Remote job
Intertek is seeking an experienced Medical Device Auditor to lead and participate in 3rd party audits across multiple sites. The role requires extensive travel (3–5 nights per week) and living in the United States. You will assess management systems for ISO 13485 compliance, train junior auditors, and interface with clients throughout the certification process. Applicants should have a biology/technical degree, 4+ years in medical device auditing, and strong communication, documentation, and #J-18808-Ljbffr Intertek CEA
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...standards of care.SUMMARYThe Lead Auditor, Quality Compliance... ...portfolio of leading medical devices. Ensure that the corporate... ...with recognized ISO, GMP, GDP, GCP, and GLP... ...the 21 CFR Part 820, ISO 13485, EU Medical Device Regulation, and MDSAP country requirements; personal...Medical deviceFull timeTemporary workWork experience placement- ...Quality Systems Specialist to ensure successful implementation of ISO 13485 compliant QMS policies and procedures. This role ensures... ...meet quality standards and customers' requirements for medical devices. Responsibilities include maintaining calibration, document control...Medical deviceDay shift
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$160k - $180k
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