PMS Quality Specialist

Complaint Specialist- Hybrid Job Description Candidates should have handsu2011on experience reviewing product complaints and determining MDR reportability in accordance with 21 CFR Part 803. Experience working in remediation or retrospective review projects is strongly preferred. Responsibilities + Review historical and current complaint files to confirm completeness and reassess MDR reportability decisions. + Apply FDA MDR definitions and decision criteria to determine whether an MDR should have been filed. + Identify missing or unclear information in complaint records and work with Quality, Regulatory, Operations, and other teams to obtain needed details. + Prepare and submit MDRs through the FDA eMDR system when reportable events are identified. + Support compliance with FDA Quality System Regulations, including complaint handling requirements under 21 CFR 820.198, while meeting tight remediation timelines. 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: u2022 Medical, dental & vision u2022 Critical Illness, Accident, and Hospital u2022 401(k) Retirement Plan u2013 Pre-tax and Roth post-tax contributions available u2022 Life Insurance (Voluntary Life & AD&D for the employee and dependents) u2022 Short and long-term disability u2022 Health Spending Account (HSA) u2022 Transportation benefits u2022 Employee Assistance Program u2022 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 13, 2026. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people Actalent is an equal opportunity employer. About Actalent Actalent is a global leader in engineering and sciences services. For more than 40 years, weu2019ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APACu2014with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day. Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at .

Created: 2026-05-08