ISO 13485 Certified Auditor- Chicago, IL (1099 Auditor)
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.
- 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.
- Certified ISO 13485:2016 Lead Auditor with comprehensive training in quality management system requirements specific to medical devices.
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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