The Fountain Group is a national staffing firm and we are currently seeking a QA Specialist I for a prominent client of ours. This position is in North Chicago, IL 60064 Details for the position are as follows:
Job Title: Quality Assurance Complaint Investigator
Location: North Chicago, IL 60064
Pay Rate: $26–$28/hour (based on experience & education)
Schedule: 1st shift, full-time (overtime offered)
Overview
We are seeking a motivated professional to join our Operations Quality Assurance team. This individual will investigate returned medical device and combination product samples, document complaint findings, and ensure compliance with regulatory and quality standards. The role requires strong organizational and communication skills, comfort working in a laboratory with PPE, and the ability to work independently while collaborating with cross-functional teams.
Key Responsibilities
- Investigate returned samples related to medical devices and combination products.
- Document product complaints, investigations, and findings in the complaint handling system.
- Identify product defects, damage, or non-medical quality issues.
- Ensure complaint documentation complies with Good Documentation Practices, GMP, and GLP.
- Identify potential reportable events and notify appropriate functional groups/management.
- Work in a biohazardous lab environment with PPE (gloves, lab coat, safety glasses).
- Safely handle sharps (e.g., needles) that may contain biohazardous material.
- Review documents and recommend improvements to processes and documentation.
- Manage workload efficiently with minimal supervision and complete special projects as needed.
- Collaborate effectively with peers, internal stakeholders, and third parties as required.
Qualifications
Required:
- Bachelor’s degree in a scientific or technical discipline OR 1–2 years of relevant work experience.
- Strong written and verbal communication skills.
- Solid organizational skills and ability to manage time effectively.
- Experience working within cross-functional teams.
- Proficiency with computer systems and word processing applications.
Preferred (Nice-to-Have):
- Experience in a laboratory environment with biohazardous materials.
- Prior exposure to pharmaceutical or medical device industries.
- Background in complaint investigations.
Work Environment
- Biohazardous laboratory setting.
- Use of Personal Protective Equipment (gloves, lab coat, safety glasses).
- Onsite role – not hybrid or remote.
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