Quality Specialist

Quality Specialist This Quality Specialist role focuses on supporting remediation activities with a strong emphasis on retrospective complaint review and medical device reportability assessments under FDA requirements. You will review both historical and newly received product complaints, determine MDR reportability in compliance with FDA regulations (21 CFR Part 803), and help ensure that complaint handling processes align with FDA Quality System Regulations. 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 complaints to determine whether an MDR should have been filed. Evaluate newly received product complaints to assess MDR reportability in accordance with 21 CFR Part 803. Identify missing or incomplete data within complaint records and work cross-functionally with Quality, Regulatory, Operations, and other teams to obtain the information needed for a defensible reportability 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. Manage or contribute to high-volume documentation reviews as part of large-scale remediation or retrospective review projects. Document findings, decisions, and justifications clearly and accurately to support audit-ready complaint and MDR files. Collaborate with cross-functional stakeholders to ensure consistent application of MDR criteria and complaint handling procedures. Work effectively in a fast-paced remediation environment with aggressive deadlines and throughput expectations. 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. Familiarity with FDA Quality System Regulations, including 21 CFR 820 and complaint handling requirements under 21 CFR 820.198. Hands-on experience reviewing historical and newly received product complaints to determine MDR reportability. 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 when evaluating complaint records and reportability decisions. Ability to work effectively in a fast-paced environment with strict remediation timelines. Proficiency in preparing clear, accurate, and compliant documentation related to complaints and MDR submissions. Additional Skills & Qualifications Bachelor's degree in a relevant field (preferred but not required). 2+ years of MDR reporting or complaint remediation experience in a medical device or pharmaceutical environment (preferred). Experience working in remediation environments with aggressive deadlines and throughput expectations. Familiarity with complaint management systems such as SAP, TrackWise, or similar platforms. Knowledge of electronic medical device records and related systems. Experience supporting remediation or retrospective review efforts in a highly regulated environment. Strong communication skills to collaborate effectively with Quality, Regulatory, Operations, and other cross-functional teams. Motivation to work on a long-term contract assignment with potential for direct hire based on performance. Work Environment Work is performed in an office setting with a hybrid schedule. You will work on-site Tuesday, Wednesday, and Thursday, and work from home on Monday and Friday. The role involves extensive review of documentation, use of complaint management systems such as SAP and TrackWise or similar platforms, and interaction with electronic medical device records. The environment is fast-paced and remediation-focused, with aggressive deadlines and throughput expectations, offering a long-term contract opportunity with the potential to transition to a direct role based on performance. Job Type & Location This is a Contract position based out of Mundelein, 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 Mundelein,IL.

Application Deadline This position is anticipated to close on May 22, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.