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Pro QC International

ISO 13485 Certified Auditor- Chicago, IL (1099 Auditor)

Pro QC International, Chicago, Illinois, United States, 60290

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ISO 13485 Certified Auditor- Chicago, IL (1099 Auditor)

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ISO 13485 Certified Auditor- Chicago, IL (1099 Auditor)

role at

Pro QC International ISO 13485 Certified Auditor- Chicago, IL (1099 Auditor)

1 week ago Be among the first 25 applicants Join to apply for the

ISO 13485 Certified Auditor- Chicago, IL (1099 Auditor)

role at

Pro QC International Seeking ISO 13485 Auditor with European MDR, 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. (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.

Seniority level

Seniority level Mid-Senior level Employment type

Employment type Full-time Job function

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