Justine Peter Sabandeja Email & Phone Number

With at least half-a-decade experience in Post-Market Surveillance in Medical Device Industry — I am equipped with skills useful in processing Product Quality Complaint, Medical Device Report preparation and Process Waste identification and reduction.I've lead ad-hoc tasks in my previous organization, completed Six Sigma project and been part of Process Improvement project. Champion of competencies such as in Collaboration, Strategic Thinking, Drives Result and Communicates Effectively. Versed in various RCA tools such as 5 whys, Fishbone, Correlation.

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  Quality Specialist - Post Market Surveillance

  Irhythm Technologies International

  Jan 2024 - Present - Manila, National Capital Region, Philippines

  • Evaluates complaints to determine reportability in accordance with 21 CFR Part 803 Medical Device Reporting, European Vigilance Reporting, etc.• Performs and/or coordinates complaint investigations and gathering of additional information, working closely with other departments to complete investigation reports.• Evaluate all information from a technical perspective to ensure appropriate analysis and investigation is complete•Ensures issues are being addressed and escalated in a timely manner• Maintains complaints log.• Participates in process improvements.• Perform other quality and regulatory-related duties as assigned.

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  Adamson University

  Political Science And Government