Product Complaint Handling

Job Purpose:

To ensure effective and timely management of product complaints by receiving, documenting, investigating, analyzing, and resolving product-related complaints in compliance with applicable regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820, MDR). The role supports continuous improvement of product quality and customer satisfaction.

Key Responsibilities:

• Receive and log product complaints from customers, sales team, or regulatory bodies in the complaint management system.
• Acknowledge receipt of complaints and communicate resolution timelines to complainants.
• Evaluate the complaint to determine if it qualifies as a reportable event per regulatory requirements.
• Coordinate with cross-functional teams (R&D, Quality, Manufacturing, etc.) to investigate root cause(s).
• Ensure timely and accurate completion of complaint investigations, CAPA initiation (if required), and closure within defined timelines.
• Document complaint details, investigation findings, corrective actions, and outcomes.
• Communicate findings and resolutions to stakeholders and customers.
• Generate monthly/quarterly complaint trend reports and risk assessments.
• Support external/internal audits and regulatory inspections by providing complaint-related documentation.
• Maintain compliance with company SOPs, ISO standards, and regulatory requirements.
• Recommend preventive actions and contribute to quality improvement initiatives.

Required Qualifications and Skills:

• Bachelor’s degree in Pharmacy, Science, Biomedical Engineering, or equivalent field.
• 3+ years of experience in product complaint handling, preferably in the medical device or pharmaceutical industry.
• Knowledge of ISO 13485, FDA regulations, MDR, and other global regulatory requirements.
• Strong analytical, problem-solving, and documentation skills.
• Familiarity with complaint management software or QMS tools (e.g., TrackWise, MasterControl, etc.).
• Excellent communication skills – written and verbal.
• Attention to detail and a commitment to quality and compliance.

Preferred Qualifications:

• Certification in Quality Management Systems or Regulatory Affairs.
• Experience in root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA).
• Exposure to CAPA, NC, and audit handling processes.