A rapidly growing, and cutting-edge Medical Device/Technology client in south Orange County is looking to identify and hire a Complaint Specialist on a long term contract basis that might have potential to transition to full time. The Complaint Specialist is responsible for leading and coordinating investigation activities for complaints reported to the company. In collaboration with engineers and subject matter experts, the Complaint Specialist will ensure complaints are investigated and documented in an appropriate manner and the information is fed back into design, development, and risk management activities.
The Complaint Specialist will be responsible for, but not limited to:
Acknowledging and documenting incoming complaints accurately and promptly.
Performing device analysis in accordance with established procedures and work instructions.
Following up with customers and appropriate personnel to gather additional information.
Analyzing and reviewing available information to determine the root cause(s) of alleged product deficiencies.
Composing detailed reports describing results from investigation activities.
Completing investigations and closing complaints in a timely and accurate manner.
Training other personnel on best practices for the complaint handling process.
Identifying patterns in complaints and propose corrective/preventive actions as required.
Requirements:
Minimum of Bachelors' Degree in a scientific or technical field with at least two years of experience in related field (highly preferred).
Training to be completed per the training plan for this position as maintained in the document control system.
ASQ certification recommended but not required.
Ability to read, analyze, and interpret complaints, and adverse events with the willingness and potential for understanding basic medical terminology.
Knowledge of quality system requirements in the US, EU, UK, Mexico, Canada, Australia, Brazil, Japan, South Korea, and other markets as they relate to complaint handling.
Curious mindset with a strong sense of integrity, accountability, and commitment to service.
Excellent writing and computer skills.
Completes work assignments independently on their own with minimal supervision/guidance.