The Complaints Investigator will be responsible to Conduct costumer complaint investigations, identify root causes and issue an investigation report. Additionally support reportability assessment to the FDA.
Main responsibilities:
Conduct and lead customer complaint investigation related to mechanical issues, hardware issues, software issues, handling issues or production issues.
Work closely with the representative team in order to understand the nature of the complaint.
Work closely with SW and HW engineers, as well as the product team to determine the root cause of failure and ensure investigations are in compliance with the companys applicable policies.
Communicate and escalate investigation results and facilitate failure investigation decision process.
Provide recommendations to prevent failure recurrence and support for nonconformance/CAPA and ECO actions.
Requirements:
Bachelors degree in engineering: BSc Biomedical / Electrical / Mechanical engineering / Materials A must.
Minimum of 2 years experience as a complaints investigator or CAPA management – A must.
Proven experience in leading complaints investigations of a multidisciplinary system, preferably in the medical device industry.
knowledge of investigative and failure analysis techniques is preferred, experience in various root cause analysis method (e.g., fish bone diagrams, decision trees, etc..) and other quality tools is required.
Ability to write and communicate clearly in English, including generating and presenting well-written reports is required.
Ability to work in an evolving, challenging, multi-disciplinary environment with multiple tasks/projects.
Excellent prioritizing, organizational, and interpersonal skills.
A get-it-done attitude.
Bachelors degree in engineering: BSc Biomedical / Electrical / Mechanical engineering / Materials A must.
Minimum of 2 years experience as a complaints investigator or CAPA management – A must.
Proven experience in leading complaints investigations of a multidisciplinary system, preferably in the medical device industry.
knowledge of investigative and failure analysis techniques is preferred, experience in various root cause analysis method (e.g., fish bone diagrams, decision trees, etc..) and other quality tools is required.
Ability to write and communicate clearly in English, including generating and presenting well-written reports is required.
Ability to work in an evolving, challenging, multi-disciplinary environment with multiple tasks/projects.
Excellent prioritizing, organizational, and interpersonal skills.
A get-it-done attitude.
This position is open to all candidates.
