Quality Technician

Adverse Event & Product Complaint Specialist

Location:

Mundelein, IL (3 days/week onsite)
Contract Length: 6 months with potential extension or conversion Pay Rate: $25–34/hr (based on experience)

Insight Global is seeking a highly detail‑oriented Adverse Event & Product Complaint Specialist to support a leading medical device organization in Mundelein, IL. This hybrid role combines responsibilities from adverse event evaluation and product complaint investigation to strengthen regulatory compliance, enhance complaint handling processes, and support a large‑scale remediation initiative.

The ideal candidate brings strong analytical skills, experience in regulated industries, and the ability to interpret complex medical, technical, and product‑related information. This position plays a critical role in ensuring compliance with FDA Medical Device Reporting (MDR) requirements, including 21 CFR 803, while also supporting root cause analysis and systemic quality improvements.

• Review new and historical product complaints to confirm data completeness and ensure alignment with regulatory standards, internal procedures, and decision logic.
• Assess complaint files to determine MDR reportability under 21 CFR 803
  , applying updated criteria, definitions, and decision trees.
• Prepare and submit MDRs through the FDA’s eMDR electronic submission portal for reportable events.
• Identify reportability concerns and elevate systemic quality issues as needed.

• Evaluate defect and cause codes associated with product complaints.
• Support root cause analysis and Corrective/Preventive Action (CAPA) activities.
• Assist in resolving systemic issues related to product performance, quality, and regulatory reporting.

• Work closely with Quality, Regulatory Affairs, R&D, Operations, and other internal teams to obtain missing information and ensure accurate complaint evaluations.
• Partner with international regulatory teams to support global reporting obligations and maintain alignment with country‑specific requirements.
• Collaborate with cross‑functional groups to ensure compliance, timely resolution, and continuous improvement of complaint handling processes.

• Education:
• Bachelor’s degree in a relevant field preferred;
  High School Diploma required.
• Experience:
• 1–2+ years of experience in product complaint handling, MDR evaluation, post‑market surveillance, regulatory affairs, or related functions.
• Experience in regulated industries such as medical device, pharmaceutical, or similar environments.
• Technical & Analytical
  
  Skills:
  
  
• Ability to interpret medical terminology, product information, and narrative complaint descriptions.
• Proficiency in defect code evaluation, root cause analysis, and CAPA processes.
• Strong analytical and critical‑thinking abilities with consistent application of decision logic.
• Soft Skills:
• Excellent time‑management skills with the ability to meet strict deadlines.
• Strong communication skills and comfort working cross‑functionally.
• Initiative‑driven, eager to learn, and capable of managing multiple priorities.