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ISO 13485 Certified Auditor- Los Angeles, CA (1099 Auditor)

salary Salary :

$35 - 45 hourly

Job Description - ISO 13485 Certified Auditor- Los Angeles, CA (1099 Auditor)



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.



Compensation: $35.00 - $45.00 per hour






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