Pro QC International
ISO 13485 Certified Auditor- Chicago, IL (1099 Auditor)
Pro QC International, Chicago, Illinois, United States, 60290
ISO 13485 Certified Auditor - Chicago, IL (1099 Auditor)
4 days ago. Be among the first 25 applicants.
Job Responsibilities
Conduct ISO 13485 audits for Class 1 Medical Devices in compliance with European MDR.
Provide timely, detailed reports and photographic evidence.
Perform internal (second-party) audits and supplier audits, evaluating quality system compliance, risk management, and regulatory readiness.
Review equipment, product, and process validation and verification activities (V&V) as per medical device regulatory expectations.
Ensure effective closure of nonconformities through CAPA processes and continuous improvement.
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 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.
Strong understanding of quality system documentation, CAPA processes, and audit follow-up.
Certifications Required
Certified ISO 13485:2016 Lead Auditor with comprehensive training.
Job type: 1099 contract
Project Duration: 2 days per audit (current project)
Shift Hours: 1st Shift (current project)
Seniority Level Mid-Senior level
Employment Type Full-time
Job Function Accounting/Auditing and Finance
Industries Transportation, Logistics, Supply Chain and Storage
Referrals increase your chances of interviewing at Pro QC International by 2x.
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Job Responsibilities
Conduct ISO 13485 audits for Class 1 Medical Devices in compliance with European MDR.
Provide timely, detailed reports and photographic evidence.
Perform internal (second-party) audits and supplier audits, evaluating quality system compliance, risk management, and regulatory readiness.
Review equipment, product, and process validation and verification activities (V&V) as per medical device regulatory expectations.
Ensure effective closure of nonconformities through CAPA processes and continuous improvement.
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 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.
Strong understanding of quality system documentation, CAPA processes, and audit follow-up.
Certifications Required
Certified ISO 13485:2016 Lead Auditor with comprehensive training.
Job type: 1099 contract
Project Duration: 2 days per audit (current project)
Shift Hours: 1st Shift (current project)
Seniority Level Mid-Senior level
Employment Type Full-time
Job Function Accounting/Auditing and Finance
Industries Transportation, Logistics, Supply Chain and Storage
Referrals increase your chances of interviewing at Pro QC International by 2x.
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