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Quality Specialist
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Actalent
Remote
$65,520 Salary, Full-Time
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Job Description
UPCOMING START CLASS
HIRINGQUALITY SPECIALISTS
- 10+ local openings! Medical Device remediation projectJob Title:
Quality Specialist Job Description Support remediation activities with a focus on retrospective complaint review reportability assessments under FDA requirements. Responsibilities Review historical complaint files as part of a remediation or retrospective review effort to verify completeness and reassess MDR reportability decisions. Apply current FDA MDR definitions, criteria, and decision trees to legacy complaints to determine whether an MDR should have been filed. Identify missing or incomplete data within complaint records and work cross-functionally with Quality, Regulatory, Operations, and other teams to obtain necessary information for a defensible decision. Prepare and submit MDRs through the FDA's electronic MDR (eMDR) system when remediation identifies reportable events. Support compliance with FDA Quality System Regulations, including complaint handling requirements under 21 CFR 820.198, within strict remediation timelines. Essential Skills Hands-on experience reviewing both historical and newly received product complaints for MDR reportability in compliance with FDA regulations (21 CFR Part 803). Working knowledge of FDA MDR regulations (21 CFR 803) and complaint handling requirements. Strong 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 attention to detail. Ability to work in a fast-paced environment. Additional Skills & Qualifications A Bachelor's degree in a relevant field is preferred but not required. At least 1+ year of experience in complaint handling, MDR evaluation, or similar regulated industry experience. 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. Work Environment Work is done in an office setting. Work on-site Tuesday, Wednesday, and Thursday, with Monday and Friday as work-from-home days. Job Type & Location This is a Contract position based out of Libertyville, IL. Pay and Benefits The pay range for this position is $28.00 - $35.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:- 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&D 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 This is a hybrid position in Libertyville,IL.