Complaint Handling NA Specialist I

KARL STORZEl Segundo, CA
7d

About The Position

We’re seeking a detail‑oriented Complaint Handling Specialist to serve as a primary point of contact for receiving, processing, investigating, and reporting product complaints. In this role, you will ensure compliance with FDA regulations, support quality improvement efforts, and help drive an exceptional customer experience.   What You’ll Do Manage assigned product complaints from intake through closure, ensuring accurate documentation and timely resolution. Conduct investigations, evaluate findings, and enter codes and data into relevant systems. Identify trends by preparing and maintaining complaint logs and trending reports. Collaborate with cross‑functional teams (Quality, R&D, Tech Support, etc.) to gather technical information and support investigations. Respond to customer inquiries via phone, email, or written communication. Maintain high levels of discretion and confidentiality when handling sensitive information. Contribute to continuous process and quality improvements. Support general department activities and additional tasks as needed.

Requirements

  • 1–2 years of experience in Quality or complaint handling (or equivalent).
  • High school diploma required.
  • Familiarity with SAP transactions related to complaints and product data.
  • Proficiency in Word, Excel, and PowerPoint.
  • Strong written and verbal communication skills.
  • Ability to multitask, stay organized, and work independently or collaboratively.
  • Strong judgment, attention to detail, and customer‑focused mindset.

Nice To Haves

  • Knowledge of Quality Management Systems, FDA/ISO regulations, GMPs, and complaint handling guidelines.
  • Problem‑solving skills and experience working with standard operating procedures.

Responsibilities

  • Manage assigned product complaints from intake through closure, ensuring accurate documentation and timely resolution.
  • Conduct investigations, evaluate findings, and enter codes and data into relevant systems.
  • Identify trends by preparing and maintaining complaint logs and trending reports.
  • Collaborate with cross‑functional teams (Quality, R&D, Tech Support, etc.) to gather technical information and support investigations.
  • Respond to customer inquiries via phone, email, or written communication.
  • Maintain high levels of discretion and confidentiality when handling sensitive information.
  • Contribute to continuous process and quality improvements.
  • Support general department activities and additional tasks as needed.
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