Quality Assurance (QA) Specialist I

The Fountain Group is currently seeking a Quality Assurance (QA) Specialist I for a prominent client of ours. This position is located at North Chicago, IL (100% Onsite). Details for the position are as follows:
 
Quality Assurance (QA) Specialist I
Location: 1401 Sheridan Road, North Chicago, IL (100% Onsite)
Pay Rate: $26–28/hr
Duration: 6-month contract (high likelihood of extension)

Job Description

The Quality Assurance (QA) Specialist I supports product complaint investigations for medical devices and combination products. This hands-on laboratory role involves testing returned product samples, performing failure investigations, documenting findings, and supporting quality and regulatory compliance activities.

• Conduct product complaint investigations, including visual inspection, functional testing, and data analysis of returned medical device and combination product samples.
• Perform testing according to approved procedures, protocols, and test methods.
• Document complaint investigations and results within complaint handling systems and laboratory records.
• Identify product defects, failures, and damage, and support root cause investigations.
• Review and verify testing data for accuracy and compliance with regulatory requirements.
• Initiate and support exception investigations and corrective actions as required.
• Prepare clear, detailed technical investigation reports and summaries.
• Maintain compliance with GMP, GLP, GxP, Good Documentation Practices, and laboratory safety requirements.
• Support laboratory process improvements, document updates, and continuous quality initiatives.
• Work in a biohazard laboratory environment while following PPE and safety protocols.

Education

• Bachelor's degree in Science, Engineering, Biotechnology, Biology, Chemistry, Biomedical Engineering, or related technical discipline required.

Required Skills

• Hands-on laboratory testing and investigation experience.
• Product complaint investigation, failure analysis, or root cause analysis experience.
• Experience executing SOP-driven test methods and laboratory procedures.
• Technical documentation and investigation report writing.
• Data interpretation, result verification, and troubleshooting of laboratory testing issues.
• Knowledge of GMP, GLP, GxP, and Good Documentation Practices.
• Experience working with laboratory instrumentation and analytical testing techniques.
• Ability to handle biohazard materials, sharps, injectable devices, and PPE requirements.
• Strong analytical skills with the ability to determine appropriate next-step testing strategies.

Preferred Skills

• Medical device or combination product testing experience.
• Experience investigating autoinjectors, prefilled syringes, or drug-device combination products.
• Complaint handling and quality systems experience.
• Experience with OneTrack, TrackWise, NuGenesis, or LIMS platforms.
• Exposure to regulated pharmaceutical, biotechnology, or medical device environments.
• Engineering background supporting product testing or failure investigations.