Occupation:Director of Quality |
Location:Sunnyvale, CA |
Education Level:Bachelor |
Will Relocate:YES |
Description
Summary: * Over 30 years of experience as Manufacturing, Equipment engineer and Supplier Quality Engineer in the Semiconductor and Bio-Pharmaceutical industry including Medical Device Products, Aerospace, Defense and Commercial industry . * Hands on experience in Manufacturing engineering, Quality and Process improvement engineering, NPI, implementations & improvements on MIL-AERO and ICOM products to meet MIL specifications and ISO9001 / ISO9002 / ISO13485 / ISO14971 Risk management and Hazard Analysis requirements. * Familiar with Control charts / Pareto charts / Defect measurement / Fishbone diagrams, Trend Analysis, SPC / Root Cause Analysis/Process and Design FMEAs / MTBA / TQM / MTBF / MTTF / FRACAS / FACA (Failure Analysis and Corrective Action System) CAPA / Control Plans, SPC, SOP, DOE, DFM / CPI / GD&T / JIT / BOM / SMED (Single minute Exchange of Die), FAIR, CAPA, SCAR's. Shelf life of Medical devices, storage and Temperature/ humidity requirements, traceability, Final marking of the medical device and the final packing of the device. Familiar with RoHs requirements. * Pharmaceutical-Biotech device industry experience in the manufacture, inspection, testing and final goods packaging (Class I, II and III) of Catheters and other Pharmaceutical devices. * Experienced and designed various Vision systems used for pattern recognition in Semiconductors and Pharmaceutical-Biotech industry. (Hands on experience) * Experience with 8 D corrective actions, 5 whys, SSQA, HALT / HASS, First Article inspections and requirements * Sampling protocols, valid sampling procedures using statistical techniques. * Strong hands on experience in R&D department in design, evaluation of designs, perform tests and final release to manufacturing. * Review new products specifications, design verifications and run evaluation tests, document all phases of the new product, publish the results to all different team members, get approvals, lead and participate in all CCB / ECN's and MRB management teams as needed. * Semiconductor industry experience includes strong background in designing, selecting, modifying /upgrading and enhancing capital Equipment such as Wafer Handlers, ATE, Laser engravers and laser alignment systems. Vision systems. Marking on different types of materials to meet MIL standards. * Extensively traveled to ASIA to set up and maintain facilities, evaluate/select and audit suppliers and sub-contractors * Conducting internal and external audits to assist and help the companies to become or continue to maintain its ISO certification.

Accomplishments
Highlights:

Keywords
- Worldwide
- Project Management
- Project Manager
- Medical Industry
- Defense
- Manufacturing
- Manufacturing Engineering
- Semiconductor Industry
- Macromedia Flash
- Project Management
- Project Manager
- Defense
- Medical
- Engineering
- HR
- Human Resources
- Macromedia Flash
- Project Management
- Project Manager
- Medical
- Defense
- Manufacturing
- Manufacturing Engineering
- Semiconductor Industry
