Quality Auditor
$32 - $35 per hourCollabera
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Days Left: 25 days, 3 hours left Apply Title: Quality Auditor Location: Mundelein, IL (Hybrid - Tuesday, Wednesday, Thursday onsite; Monday & Friday remote) Pay Range: $32/hr-$35/hr Benefits: 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 , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable Details: 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. 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
- Complaint Handling
- FDA
- MDR
- CFR
- Auditing
- Recruiter
- Phone
- Vikas Sharma
- View email address on click.appcast.io
Vacancy posted 2 days ago
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