Auditor

Title:

Quality Auditor

Schedule:

Hybrid (3x onsite) Duration: 3-6 months Contract + extension

Location:

Mundelein, IL 60060 Payrange: $28-30/hr Mission:
Ensure the accuracy, completeness, and compliance of product complaint documentation by conducting thorough quality audits, identifying trends and discrepancies, and partnering with cross-functional teams to maintain high-quality standards in support of regulatory and business objectives. Day-to-Day:
We are looking for a Quality Auditor to perform detailed audits of product complaint files, adverse event documentation, and quality records to ensure compliance with FDA regulations, internal procedures, and quality system requirements. This individual will review documentation for accuracy and completeness, identify trends and opportunities for process improvement, communicate audit findings to stakeholders, and collaborate with complaint handling, regulatory, and quality teams to ensure corrective actions are implemented.

The ideal candidate has exceptional attention to detail, strong analytical skills, and the ability to clearly communicate findings while maintaining a high level of accuracy. Must Haves: 3+ years of Quality Assurance or Quality Auditing experience within the medical device, pharmaceutical, or healthcare industry Hands-on experience conducting quality audits of regulated documentation (product complaints, adverse events, CAPAs, or similar) Exceptional attention to detail with the ability to identify documentation errors, inconsistencies, and compliance gaps Strong understanding of FDA Quality System Regulations (21 CFR Part 820) and/or ISO 13485 Excellent written and verbal communication skills with experience presenting audit findings and collaborating across teams Proficiency with MS Office/Excel and quality management/document control systems Plusses:
Experience auditing Medical Device Reporting (MDR) documentation Knowledge of complaint handling and post-market surveillance processes Lean Six Sigma or Quality Auditor certification (ASQ CQA) Interested candidates can send their resume to an or reach me directly at  The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable.