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ISO 13485 Certified Auditor- Chicago, IL (1099 Auditor)

ISO 13485 Certified Auditor- Chicago, IL (1099 Auditor)

Pro QC International North AmericaChicago, IL, US
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Job Description

Job Description

Job Responsibilities :

  • Seeking ISO 13485 Auditor with European MDR, but only for Class 1 Medical Devices
  • Provides timely, detailed reports and photographic evidence.

Industry Experience :

  • Proven experience conducting internal (second-party) audits and supplier audits in compliance with ISO 13485, ISO 9001, FDA 21 CFR Part 820, EU MDR, and GMP standards.
  • Demonstrated expertise in evaluating both new and existing suppliers for quality system compliance, risk management, and regulatory readiness.
  • Skilled in performing and reviewing equipment, product, and process validation and verification (V&V) activities in accordance with medical device regulatory expectations.
  • Strong understanding of quality system documentation, CAPA processes, and audit follow-up to ensure effective closure of nonconformities and continuous improvement.

    • Certifications Required :

  • Certified ISO 13485 : 2016 Lead Auditor with comprehensive training in quality management system requirements specific to medical devices.

    • Job type : 1099 contract

    Project Duration : 2 days per audit. (CURRENT PROJECT)

    NOTE : in a 1099 Contract, Project duration varies project to project.

    Shift Hours : 1st Shift (CURRENT PROJECT)

    NOTE : in a 1099 Contract, duration varies from project to project.

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    Chicago Chicago Il • Chicago, IL, US