ISO 13485 Certified Auditor- Chicago, IL (1099 Auditor)
Pro QC InternationalChicago, IL, USjob_description.job_card.30_days_ago
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- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionProven 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. Certified ISO 13485 : 2016 Lead Auditor with comprehensive training in quality management system requirements specific to medical devices.
Job Title
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 :
Certifications Required :
Job Type : 1099 Contract Project Duration : 2 days per audit. (CURRENT PROJECT) Shift Hours : 1st Shift (CURRENT PROJECT) NOTE : in a 1099 Contract, Project duration varies project to project.
Compensation : $35.00 - $45.00 per hour
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Chicago Chicago Il • Chicago, IL, US
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