14 Oct
|
Heartstream
|
Bengaluru
14 Oct
Heartstream
Bengaluru
Complaint Handling (CH) & Vigilance Reporting Specialist
Heartstream is building on our 40+ year legacy of growth and innovation in emergency medical technology to continue passionately pursuing our mission of saving lives, lowering the cost of healthcare, and advancing the science of resuscitation while serving the public access AED, EMS, military, and hospital market segments. Heartstream includes leading brands and products like HeartStart AEDs, Intrepid and DFM100 monitor defibrillators, Tempus monitor and Tempus ALS systems, and Corsium and ECI informatics solutions.
Your impact:
• Play a critical role in ensuring the quality, safety, and effectiveness of Heartstream's life-saving medical technologies by leading investigations into post-market complaints and adverse events.
• Conduct complex complaint investigations, analyzing customer feedback, product performance data, technical findings, and service records to identify potential product issues, determine root causes, and support timely resolution.
• Lead end-to-end complaint handling activities, including data collection,
coding, documentation, analysis, investigation planning, reporting, and closure in compliance with quality and regulatory requirements.
• Collaborate closely with cross-functional stakeholders including Quality, Regulatory Affairs, Engineering, Clinical, Manufacturing, Service, and Product Management teams to support technical investigations and drive corrective actions where required.
• Utilise complaint and post-market surveillance data to identify trends, safety concerns, and opportunities for product improvements that enhance customer experience and patient outcomes.
• Review and approve customer response communications, ensuring investigations are thoroughly documented and escalated appropriately when regulatory reporting or additional actions are required.
• Support the continuous improvement of complaint handling processes by maintaining coding standards, ensuring data integrity, a
📌 Complaint Handling and Vigilance Reporting Specialist (Bengaluru)
🏢 Heartstream
📍 Bengaluru