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MDR complaint Specialist/ Quality Specialist

Job

Ace Technologies, Inc.

Mundelein, IL (In Person)

Full-Time

Posted 3 days ago (Updated 13 hours ago) • Actively hiring

Expires 6/12/2026

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Job Description

MDR complaint Specialist / Quality Specialist Onsite Mundeline , IL Need to be able to start onsite on the 25th Essential Skills
  • At least 1+ year of experience in complaint handling, MDR evaluation, or similar experience within a regulated industry.
  • Working knowledge of FDA MDR regulations (21 CFR 803) and complaint handling requirements.
  • Understanding of FDA Quality System Regulations, including 21 CFR 820 and complaint handling under 21 CFR 820.198.
  • Hands-on experience reviewing product complaints to determine MDR reportability in compliance with FDA regulations.
  • Experience managing high-volume documentation reviews or participating in large-scale remediation or retrospective review projects.
  • Strong ability to interpret medical narratives, product information, and adverse event descriptions to assess severity, outcome, and reportability.
  • Strong analytical skills and a high level of attention to detail.
  • Ability to work effectively in a fast-paced environment and meet aggressive deadlines.
  • Proficiency with electronic medical device records and documentation practices.
  • Effective communication and collaboration skills for working with cross-functional teams. Additional Skills & Qualifications
  • Bachelor s degree in a relevant field is beneficial but not required.
  • 2+ years of MDR reporting or complaint remediation experience in a medical device or pharmaceutical environment is preferred.
  • Experience working in remediation environments with aggressive deadlines and throughput expectations.
  • Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms.
  • Experience supporting remediation or retrospective review efforts for regulatory compliance.
  • Demonstrated ability to maintain organized records and documentation in support of audits and inspections.

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