Quality Specialist
Actalent, Mundelein, IL, United States
Quality Specialist
The Quality Specialist supports remediation activities with a primary focus on retrospective complaint review and medical device reportability assessments in alignment with FDA requirements. This role reviews both historical and newly received product complaints to determine MDR reportability under 21 CFR Part 803, ensuring accurate documentation and compliance within strict remediation timelines.
Responsibilities
Review historical complaint files as part of remediation or retrospective review efforts to verify completeness and reassess MDR reportability decisions.
Apply current FDA MDR definitions, criteria, and decision trees to legacy and new complaints to determine whether an MDR should have been filed or should be filed.
Identify missing or incomplete data within complaint records and work cross‑functionally with Quality, Regulatory, Operations, and other stakeholders to obtain necessary information for a defensible decision.
Prepare and submit MDRs through the FDA’s electronic MDR (eMDR) system when remediation activities identify reportable events.
Support compliance with FDA Quality System Regulations, including complaint handling requirements under 21 CFR 820.198, throughout remediation activities.
Manage or participate in high‑volume documentation reviews as part of large‑scale remediation or retrospective review projects.
Maintain accurate, thorough, and audit‑ready documentation that supports complaint investigations and MDR decisions.
Work efficiently within aggressive deadlines and throughput expectations while maintaining high quality and attention to detail.
Essential Skills
At least 1+ year of experience in complaint handling, MDR evaluation, or similar experience in a regulated industry.
Working knowledge of FDA MDR regulations (21 CFR 803) and complaint handling requirements.
Ability to interpret medical narratives, product information, and adverse event descriptions to assess severity, outcome, and reportability.
Experience managing high‑volume documentation reviews or participating in large‑scale remediation or retrospective review projects.
Strong analytical skills and exceptional attention to detail.
Ability to work effectively in a fast‑paced environment.
Familiarity with FDA Quality System Regulations, including 21 CFR 820 and electronic medical device records.
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.
Strong documentation skills and comfort working with electronic systems and databases.
Ability to collaborate effectively with cross‑functional teams including Quality, Regulatory, and Operations.
Job Type & Location
Contract position based out of Mundelein, IL.
Pay And Benefits
Pay range: $30.00 – $32.00 /hr.
Benefits
Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
Life Insurance (Voluntary Life & AD&DD for the employee and dependents)
Short and long‑term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
Hybrid position in Mundelein, IL.
Application Deadline
Position anticipated to close on May 1 2026.
Equal Opportunity Employer
Actalent is an equal opportunity employer.
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The Quality Specialist supports remediation activities with a primary focus on retrospective complaint review and medical device reportability assessments in alignment with FDA requirements. This role reviews both historical and newly received product complaints to determine MDR reportability under 21 CFR Part 803, ensuring accurate documentation and compliance within strict remediation timelines.
Responsibilities
Review historical complaint files as part of remediation or retrospective review efforts to verify completeness and reassess MDR reportability decisions.
Apply current FDA MDR definitions, criteria, and decision trees to legacy and new complaints to determine whether an MDR should have been filed or should be filed.
Identify missing or incomplete data within complaint records and work cross‑functionally with Quality, Regulatory, Operations, and other stakeholders to obtain necessary information for a defensible decision.
Prepare and submit MDRs through the FDA’s electronic MDR (eMDR) system when remediation activities identify reportable events.
Support compliance with FDA Quality System Regulations, including complaint handling requirements under 21 CFR 820.198, throughout remediation activities.
Manage or participate in high‑volume documentation reviews as part of large‑scale remediation or retrospective review projects.
Maintain accurate, thorough, and audit‑ready documentation that supports complaint investigations and MDR decisions.
Work efficiently within aggressive deadlines and throughput expectations while maintaining high quality and attention to detail.
Essential Skills
At least 1+ year of experience in complaint handling, MDR evaluation, or similar experience in a regulated industry.
Working knowledge of FDA MDR regulations (21 CFR 803) and complaint handling requirements.
Ability to interpret medical narratives, product information, and adverse event descriptions to assess severity, outcome, and reportability.
Experience managing high‑volume documentation reviews or participating in large‑scale remediation or retrospective review projects.
Strong analytical skills and exceptional attention to detail.
Ability to work effectively in a fast‑paced environment.
Familiarity with FDA Quality System Regulations, including 21 CFR 820 and electronic medical device records.
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.
Strong documentation skills and comfort working with electronic systems and databases.
Ability to collaborate effectively with cross‑functional teams including Quality, Regulatory, and Operations.
Job Type & Location
Contract position based out of Mundelein, IL.
Pay And Benefits
Pay range: $30.00 – $32.00 /hr.
Benefits
Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
Life Insurance (Voluntary Life & AD&DD for the employee and dependents)
Short and long‑term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
Hybrid position in Mundelein, IL.
Application Deadline
Position anticipated to close on May 1 2026.
Equal Opportunity Employer
Actalent is an equal opportunity employer.
#J-18808-Ljbffr