Quality Auditor
$30 - $32 per hourCollabera
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Days Left: 25 days, 3 hours left Apply 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
- 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
- Medical Device Reporting (MDR) audit experience
- Knowledge of complaint handling/post-market surveillance
- ASQ CQA or Lean Six Sigma certification
- FDA
- CAPA
- CFR
- Audit
- Quality
- Recruiter
- Phone
- Eshika Jain
- View email address on click.appcast.io
Vacancy posted 4 days ago
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