Quality Specialist (MDR)

Job Title:

Quality Specialist Job Description The Quality Specialist supports remediation activities with a primary focus on retrospective complaint review and MDR reportability assessments in alignment with FDA requirements. This role involves reviewing historical and newly received product complaints, reassessing prior reportability decisions, and ensuring that all MDR submissions comply with 21 CFR Part 803 and related FDA Quality System Regulations. The position is ideal for someone who is detail-oriented, comfortable managing high volumes of documentation, and experienced in working within a regulated medical device or pharmaceutical environment. Responsibilities Review historical complaint files as part of remediation or retrospective review efforts to verify completeness and reassess MDR reportability decisions. Evaluate newly received product complaints to determine MDR reportability in compliance with FDA regulations (21 CFR Part 803). 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 collaborate cross-functionally with Quality, Regulatory, Operations, and other teams to obtain necessary information for defensible decisions. 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, while meeting strict remediation timelines. Manage and prioritize high volumes of documentation reviews to support large-scale remediation or retrospective review projects. Maintain accurate, clear, and complete documentation to support audits, inspections, and internal quality system requirements. Interpret medical narratives, product information, and adverse event descriptions to assess severity, outcome, and reportability. Contribute to continuous improvement of complaint handling and remediation processes by sharing insights and observations from review activities. 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. Work Environment Work is performed in an office setting within a regulated medical device or pharmaceutical environment. The role follows a hybrid schedule, with on-site work required on Tuesday, Wednesday, and Thursday, and remote work from home on Monday and Friday. The position involves extensive computer-based review of electronic medical device records and use of complaint management systems such as SAP, TrackWise, or similar platforms. The environment is fast-paced, deadline-driven, and focused on large-scale remediation and documentation accuracy, 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 15, 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.