Certified Complaint Technician(Medical Device) 40k-45k #2

Complaint Technician

We are currently looking for a Complaint Technician, based out of our world headquarters located in Irvine, CA. The Complaint Technician is a technical position that is responsible for receiving, documenting and performing complaint evaluations of  products according to FDA, European and Canadian requirements for medical device customer complaints.  This position interfaces with the Service and other departments.  In the identification, resolution of customer complaints and complaint product returns. Duties and responsibilities include, but are not limited to:

• Establish and maintain complete complaint files and CRM records for all laser system complaint units according to the complaint system procedures/process.
• Perform detailed root cause analysis to determine the specific failure mode down to the component or assembly.  For purchased assemblies such as power supplies, PCBAs, electro-mechanical assemblies, etc. the technician must ensure that they are sent out to suppliers and must follow up with them to obtain root cause analysis results.
• Filing and maintenance of all compliant files and records according to established procedures and requirements.
• Other activities and responsibilities as determined by the Quality Systems Manager or QA Director
• Certified Technician
• Perform minor repair, rework and refurbishment on laser systems as required.

We are looking for an organized individual with 3 years of experience in the medical device industry, preferable with at least 1 year recent experience in a medical device customer complaint or CAPA group. AS degree in a technical discipline or Certified Technician. Excellent written and verbal communication skills.