Adverse Events, American Society for Quality (ASQ), Analysis Skills, Auditing, Biotech and Pharmaceutical, Code of Federal Regulations, Communication Skills, Control Systems, Corrective Action, Cross-Functional, Detail Oriented, Document Control, Documentation, Documentation Review, FDA Requirements, Healthcare, ISO (International Organization for Standardization), Lean Six Sigma, Maintain Compliance, Medical Equipment, Microsoft Excel, Microsoft Office, Presentation/Verbal Skills, Process Improvement, Product Documentation, Quality Assurance, Quality Management, Quality Metrics, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Surveillance, Trend Analysis, Writing Skills
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:
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 aneesha.chowdhury@collabera.com or reach me directly at 312.724.7929
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.
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Collabera
Since 1991, Collabera has been a leading provider of IT staffing solutions and services. We are known for providing the best staffing experience and taking great care of our clients and employees.
Our client-centric model provides focus, commitment and a dedicated team to help our clients achieve their business objectives. For consultants and employees, we offer an enriching experience that promotes career growth and lifelong learning.
The Collabera Way represents our fundamentals beliefs and is founded on the following building blocks:
10,000 employees or more
Staffing/Employment Agencies