Responsibilities

Receive and evaluate customer complaints related to our medical devices, ensuring timely and effective resolution.

Conduct thorough investigations into reported issues, utilizing engineering principles and problem-solving techniques.

Collect and analyze complaint data, product specifications, and relevant documentation to identify trends, patterns, and potential safety risks.

Collaborate with cross-functional teams, including product development, quality assurance, and regulatory affairs, to determine root causes and implement corrective and preventive actions.

Conduct technical tests, experiments, or simulations to replicate and understand reported issues.

Prepare detailed investigation reports, including findings, analysis, and recommendations for corrective actions.

Communicate with customers, regulatory authorities, and other stakeholders to gather additional information and provide updates on investigation progress.

Ensure compliance with applicable medical devices regulations, quality standards (e.g., FDA regulations, ISO 13485), and internal procedures throughout the complaint handling process.

Participate in design and process improvement discussions, providing input based on complaint analysis and customer feedback.

Assist in the development and implementation of effective complaint handling procedures and systems.

Stay updated on industry regulations, standards, and emerging trends related to medical devices complaint handling and quality management.