Complaints Handler

Stellar Consulting Solutions, LLC; Vernon Hills (IL); Hybrid; USD 52,348 - 55,104; Full time

Job summary

A renowned consulting firm is seeking a Quality Systems Specialist to manage customer complaints while ensuring compliance with FDA and ISO regulations. This role involves continuous improvement in product quality and customer satisfaction. Ideal candidates have a bachelor’s degree and experience in quality systems within the medical device or pharmaceutical industry. The position offers a hybrid work setup, with some onsite requirements.

Qualifications

• Bachelor’s degree preferred in Clinical, Science, or Engineering.
• 2–3 years in Quality Systems, Regulatory Affairs, or medical device/pharma.
• Working knowledge of FDA and ISO quality system regulations.

Responsibilities

• Manage the end-to-end customer complaint process.
• Conduct root cause analyses and recommend CAPA.
• Collaborate with cross-functional teams to resolve issues.

Skills

Analytical skills

Communication skills

Problem-solving skills

Education

Bachelor’s degree in Clinical, Science, or Engineering

Tools

TrackWise

Microsoft Excel

Microsoft Word

Microsoft PowerPoint

Job description

Stellar Consulting Solutions, LLC provided pay range

This range is provided by Stellar Consulting Solutions, LLC. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$38.00/hr - $40.00/hr

Job Title: Quality Systems Specialist-Complaints Handling

Location: Vernon Hills, IL Hybrid (2 days onsite, remainder remote)

Duration: 9+Months

Job Summary

The Quality Systems Specialist supports the company’s Quality Management System (QMS) by managing customer complaints, ensuring compliance with FDA and ISO regulations, and contributing to continuous improvement in product quality and customer satisfaction.

Key Responsibilities

• Apply Quality System standards consistently across assigned areas.
• Manage the end-to-end customer complaint process, including review, investigation, documentation, and response.
• Conduct root cause analyses and recommend corrective/preventive actions (CAPA).
• Identify and track complaint trends to support product and process improvements.
• Prepare investigation reports and complaint closure letters.
• Review and validate all complaints for compliance with internal policies and regulatory requirements.
• Determine if complaints meet Medical Device Reporting (MDR) criteria and prepare Med Watch reports when applicable.
• Collaborate with Regional Complaint Centers and cross-functional teams to resolve issues.
• Use complaint databases (e.g., TrackWise) and develop quality metrics and reports.
• Provide internal guidance and training on complaint handling and regulatory compliance.
• Support internal and cross-business quality projects and continuous improvement initiatives.

Qualifications

• Education: Bachelor’s degree (preferred in Clinical, Science, or Engineering field).
• Experience: 2–3 years in Quality Systems, Regulatory Affairs, or related medical device/pharma industry role.
• Working knowledge of FDA and ISO quality system regulations.
• Experience with complaint handling systems (TrackWise preferred).
• Proficiency in Microsoft Excel, Word, and PowerPoint.
• Strong analytical, communication, and problem-solving skills.