Product Complaint Handling

4 weeks ago

Surat, Gujarat, India Concept Medical Full time

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.

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