The Complaint Coordinator is responsible for the ongoing administration, supervision and continuous improvement of Regulatory, Clinical and Quality systems to ensure compliance with US, Europe, Canada, Australia, and other international complaint handling/device reporting requirements.
Responsible for receiving, documenting and coordinating investigation on product complaints.
Ensure timely investigation of product complaints. This involves initiating, participating and documenting investigations and corrective action arising from products complaints.
Responsible to review, analyze, summarize and interpret data; draw conclusions and make recommendations and decisions regarding complaint investigations.
Collaborates with Sales personnel, Customer service, Engineering, Manufacturing, Quality Assurance, Clinical Affairs, EU Authorized Representative, Distributors and 3rd Parties in these investigations.
Maintains current and complete complaint files.
Requirements:
Student in health science discipline or related area.
Strong communication, organizational and time-management skills required.
Excellent computer and presentation skills including Microsoft Word, Excel, PowerPoint and Adobe Acrobat.
Ability to work cross-functionally to resolve issues in a timely manner.
Fluent in written and spoken English
Experience in Medical Device industry / Healthcare organizations or related industry advantage.
Experience in complaint handling per 21 CFR Part 820 and ISO 13485 is preferred - advantage.