Corey Kasbohm Email & Phone Number

Bothell, Wa

Coordinates complaint intake, evaluation, and investigation activitiesAssesses complaints for Medical Device Reporting (MDR), Mandatory Problem Report (MPR), and Vigilance reporting requirementsPrepares and submits MDR / Vigilance reports to US and global agencies as requiredAuthorizes closure of potentially critical complaintsEscalates issues that may require corrective actionGenerates quality data for product quality trending and improvement opportunityManagement of complaint, Medical Device and Vigilance Reporting FilesProvides training for complaint intake and returned device evaluationInteracts with Customer Care to support complaint data intake requirements and complainant follow-up

Bothell, Wa

Coordinates complaint intake, evaluation, and investigation activitiesAssesses complaints for Medical Device Reporting (MDR), Mandatory Problem Report (MPR), and Vigilance reporting requirementsPrepares and submits MDR / Vigilance reports to US and global agencies as requiredAuthorizes closure of potentially critical complaintsEscalates issues that may require corrective actionGenerates quality data for product quality trending and improvement opportunityManagement of complaint, Medical Device and Vigilance Reporting FilesProvides training for complaint intake and returned device evaluationInteracts with Customer Care to support complaint data intake requirements and complainant follow-up

Seattle, Washington

Irvine, Ca

Responsible for complaint and compliance handling for our Transcatheter Heart Valve product. Process and investigate customer complaints for Transcatheter Heart Valve products while maintaining compliance to all regulations. Prepares customer responses, metrics and ad hoc reports

Irvine, Ca

This position is responsible for the ongoing administration, supervision and continuous improvement of Quality Systems to ensure compliance with US, European, Canadian, and international regulatory compliance and complaint handling/device reporting requirements. This position also is responsible for the timely completion of assigned activities related to regulatory compliance support activities worldwide.

Received incoming complaint reports on real and/or perceived issues via phone / written reports. Work closely with device users to understand issues and ensure adequate resolution. Ensured records of complaint investigation are adequate, accurate and timely and coordinate the return of material and/or product for analysis. Provide technical (product) and clinical support to customers, field sales and service personnel regarding device operation. Wrote and submitted MDRs and/or Vigilance reports in accordance with regulatory requirements.

Perform preventive maintenance evaluations and repairs to the following Biomedical equipment:Respiratory HumidifiersCPAP units used in the treatment of Obstructive Sleep ApneaInfant Warmers with the Neopuff Infant ResuscitatorsField Technical Support phone calls on the use and repair of the wide variety of Fisher & Paykel products used by a variety of healthcare institutions, including CPAP machines and interface devices

Performed routine Preventive Scheduled Maintenance, Unscheduled Repairs and perform monthly systems checks on the INOvent delivery system, used in the treatment of term and near-term neonates with hypoxic respiratory failure (HRF) associated with clinical or echocardiographic evidence of pulmonary hypertension Maintained an inventory of parts used in the maintenance and repair of the INOvent to a high accuracy rate. Was responsible for the proper record keeping and service history for devices that passed through our regional center. Became very familiar with FDA guidelines and cGMP guidelines

Perform alignment and repairs, to component level, on Nortel Polaris and Tiger Paw Single Channel Linear Power Amplifiers TDMA type and Nortel Cajun; Multiple Channel Linear Power Amplifiers W-CDMA type using equipment such as multimeter, spectrum analyzers, network analyzers, and windows base test programs. Performed routine maintenance, calibration, repairs to Automated Test Equipment on the following equipment:Spectrum AnalyzersNetwork AnalyzersSignal GeneratorsAssociated wiring and RF cabling

Performed maintenance and repairs to Digital Data Link Systems and Instrument Land Systems while stationed in Whidbey Island WashingtonAssigned Temporary Duty in the IRML office tasked with inventory control of test equipment on temporary loan the various squadrons on baseMaintained and repaired Radar Altimeters Trained extensively in cable manufacturing, repair and solder techniquesAssigned to the USS Carl Vinson for a 6 month tour of the Persian GulfAboard ship I maintained and repaired the following equipment:Digital Data Link SystemsInstrument Land SystemsRadar Altimeters