E-Te Chane Email & Phone Number

San Francisco, California, Us

Supply Quality Engineer. Oversea Contract Manufacturing ISO 13485 audit. Plant relocation audit.

San Francisco, Ca, Us

• Responsible for Supplier Quality Engineering. Incoming Quality Assurance, Supplier Qualification and Corrective Action. Facilitate Supplier performs Process pFMEA.• Responsible for NCMR (Nonconforming Material Review process)• Manufacturing Quality support on process pFMEA manufacturing process instructions. • Complied with company design control requirements / employee personal training requirements -- cGMP (Current Good Manufacturing Practice; 21 CFR 820)

San Clemente, Ca, Us

•Extensive 20 years experience with the Cadence PCB Design Tools; Concept HDL / OrCAD Capture CIS schematic capture and Allegro layout.•Developed detail oriented, Bill of Materials, PCB fabrication specifications, Assembly Drawings, DFM and ICT test ability.•Design products to meet compliances IEC 60601-1-2, 60601-1-1 (SIP/SOP Safety requirements), 60601-1-2-24 and 60601-1-2-49. •Skilled include AutoCAD, MS Professional Office 2003, and Visio 2003. Experienced in Agile and MatrixOne/Enovia operating environment for design control. SAP for documentation control. •28 years of experience on Critical Care Patient Monitoring equipments including Continuous Cardiac Output Computer (CCO), Oximeter (continues SvO2 monitoring through Optical Module and Catheter), EKG monitor, and BP transmitter/receiver. •Skilled in the use of general test equipment. Electro-mechanical root causes troubleshooting and repair of printer circuit board assembly to the component level.•Strong Verbal and Written Communications Skills.•Desgin Control for Medical device.