Adverse Events, American Society for Quality (ASQ), Analysis Skills, Auditing, Biotech and Pharmaceutical, Code of Federal Regulations, Communication Skills, Corrective Action, Cross-Functional, Detail Oriented, Documentation, FDA (Food and Drug Administration), FDA Requirements, Healthcare, ISO (International Organization for Standardization), Lean Six Sigma, Maintain Compliance, Medical Equipment, Microsoft Excel, Microsoft Office, Process Improvement, Product Documentation, Quality Assurance, Quality Management, Quality Metrics, Regulations, Regulatory Compliance, Six Sigma Certification, Surveillance, Trend Analysis
Hiring for Quality Auditor
Location: Mundelein, IL (Hybrid: Tues–Thurs onsite | Mon & Fri remote)
Duration: 3–6 Month Contract
Openings: 5
Pay Range: $30-32/hr
About the Role:
We're hiring Quality Auditors to ensure the accuracy, completeness, and compliance of product complaint documentation in a regulated healthcare environment. You'll conduct quality audits, identify documentation gaps, communicate findings, and collaborate with cross-functional teams to support regulatory and quality standards.
Key Responsibilities:
- Audit product complaint, adverse event, and quality documentation
- Ensure compliance with FDA regulations and internal quality procedures
- Identify trends, documentation gaps, and process improvement opportunities
- Present audit findings and support corrective actions
- Partner with Quality, Regulatory, and Complaint Handling teams
Required Qualifications:
- 3+ years of Quality Assurance/Quality Auditing experience in medical device, pharmaceutical, or healthcare
- Experience auditing regulated documentation (product complaints, adverse events, CAPAs, etc.)
- Knowledge of FDA 21 CFR Part 820 and/or ISO 13485
- Strong attention to detail and analytical skills
- Excellent communication and proficiency with MS Office/Excel and quality management systems
Nice to Have:
- Medical Device Reporting (MDR) audit experience
- Knowledge of complaint handling/post-market surveillance
- ASQ CQA or Lean Six Sigma certification
Interview Process: Two 15-minute interview rounds.
Interested cndidates can share their resumes to eshika.jain@collabera.com or an reach me at 312-571-8967.
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