Quality Auditor

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 candidates can share their resumes to View email address on click.appcast.io or reach me at View phone number on click.appcast.io.

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.