Manager Technical Services
Manage Internal and Field Service Activities for Internal R&D, Clinical Support and Third Party Marketing and Service both Domestic and International.Manage daily activities for ongoing Preventative Maintenance Support activities, Installation and Field Service scheduling.Support Manufacturing personnel on training of new product assembly procedures, in process testing and final testing acceptance criteria. Participate in the design of Medical Devices, design in for serviceability Develop Preventative Maintenance Schedules, write and release Field Change Orders, maintain Field Service Reports and Instrument Device History Records.Write Standard Operating Procedures (SOP) Develop assembly procedures for manufacturingParticipate in Instrument validation, MTBF, Software Testing and Hardware Failure analysis.Write and Develop Receiving Specifications for incoming Raw Materials inspection.Comply with FDA and ISO 13485 Audits.Trained as an Internal Auditor Trained on Demand Flow Technology for manufacturing.Responsible for completing customer complaints and documenting resolution methods, meeting with Quality Assurance and company wide departments to insure methods and corrective actions are implemented.Trained on Juran Quality PracticesTrained on cGMP, GLP and ISO practices and procedures.Supported Quality Assurance and Quality Control departments on material inspection, testing and inventory document requirements.