ISO 13485 Certified Auditor- San Francisco, CA (1099 Auditor) (San Francisco)

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.