Pro QC International
ISO 13485 Certified Auditor- San Francisco, CA (1099 Auditor)
Pro QC International, San Francisco, California, United States, 94199
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ISO 13485 Certified Auditor- San Francisco, CA (1099 Auditor)
role at
Pro QC International We are seeking an ISO 13485 Auditor with European MDR experience, but only for Class 1 Medical Devices. Provides timely, detailed reports and photographic evidence. 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. Shift Hours:
1st Shift Seniority level
Mid-Senior level Employment type
Full-time Job function
Accounting/Auditing and Finance
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ISO 13485 Certified Auditor- San Francisco, CA (1099 Auditor)
role at
Pro QC International We are seeking an ISO 13485 Auditor with European MDR experience, but only for Class 1 Medical Devices. Provides timely, detailed reports and photographic evidence. 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. Shift Hours:
1st Shift Seniority level
Mid-Senior level Employment type
Full-time Job function
Accounting/Auditing and Finance
#J-18808-Ljbffr