Complaint Handling Specialist

Job Description

Summary:

This role provides support to the complaint management team and will be responsible for complaint evaluation and investigation activities while ensuring complaint handling tasks are completed as required and are compliant with internal procedures and applicable external, industry regulations/standards.

• Responsible for investigating, documenting, and resolving product complaints in compliance with regulatory requirements and internal procedures at El Paso, TX Plant.

• Receive, log, and process incoming product complaints from various sources, ensuring accuracy and completeness of initial information.
• Conduct thorough investigations into reported product complaints, including gathering additional information, reviewing batch records, and coordinating with other departments (e.g., Quality, Engineering, Manufacturing).
• Perform root cause analysis for identified complaint trends and individual high-impact complaints.
• Document all complaint investigation activities, findings, and resolutions in a clear, concise, and timely manner within the designated quality management system.
• Communicate effectively with complainants, internal stakeholders, and regulatory bodies as required throughout the complaint resolution process.
• Ensure all complaint handling activities adhere to FDA, ISO, and other relevant regulatory guidelines and company policies.
• Identify and elevate potential product safety issues or critical quality trends to management.
• Participate in continuous improvement initiatives related to the complaint handling process.
• Prepare and present complaint metrics and trends to management.

• Bachelor's degree in a scientific, engineering, or related technical field preferred.
• 2+ years of experience in a regulated industry (e.g., medical device, pharmaceutical, or biotechnology), with direct experience in complaint handling, quality assurance, or regulatory affairs.
• Strong understanding of quality management systems (e.g., ISO 13485, 21 CFR Part 820) and regulatory requirements for medical devices.
• Excellent written and verbal communication skills, with the ability to articulate complex technical information clearly.
• Proficiency in root cause analysis methodologies (e.g., 5 Whys, Fishbone diagrams).
• Strong analytical and problem-solving skills with meticulous attention to detail.
• Ability to work independently and as part of a team in a fast-paced environment.
• Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint).
• Experience with quality management software (e.g., Track Wise, Pilgrim) is a plus.