Local candidates only; Manager wants interviews to be onsite.
Desk Based, File Manager Role (2 Positions)
Initiate and manage complaint files. Complaints will come from the field for the devices in Electrophysiology capital equipment or disposable devices such as Electrophysiology ablation catheters.
Communicating with field personnel who submitted that complaint and making sure their complaints are solved, documentation is completed, and meets all requirements as per FDA regulations.
Prepare customer request letters and work with lab personnel in reviewing the investigation, and assessing for reportability.
Lab Position (1 Position)
Taking complaints that are returned and doing complaint investigations on that particular complaint device.
They will be using manufacturing and design documentation to determine whether or not to verify the report of event.
Writing an investigation that summarizes their findings.
Use various electrical, dimensional or functional techniques to determine the root cause of the complaint.
Must be comfortable working with devices which are used by patients and can be contaminated as they will work on returned products. They will be cleaned before it reaches them but still, they must be okay with working on it.
Work in a clean room environment.
Experience/Knowledge/Skills Needed For Both Positions
Comply with FDA regulations and work with multiple cross-functional teams.
Any previous med device complaints handling exp is helpful; Keywords - reportability, medical technology, and lab exp.
Excellent documentation and writing skills. Strong oral communication as they need to work cross-functionally a lot.
Problem solving skills.
Education And Experience
Bachelor's degree preferred (Biology or related) ; 0 to 2 years of experience.
Recent college graduates: have lab exp in academics or have done some internship in healthcare/med device field that has given them reportability/lab-related skills.