Rona Wu's Email Addresses & Phone Numbers

📖 Summary

Principal Quality Engineer @ Stryker · Provided quality assurance support to all functions with a focus on design control and risk management in compliance with ISO 13485, 21 CFR Part 820 and 93/42/EEC.· Provided guidelines for all phase design reviews and validation to ensure that the design and development meets FDA Design Control Regulations· Managed the validation activities for bio-compatibility, packaging, shelf life, sterilization, and test methods. From February 2014 to December 2014 (11 months) San JosePrincipal Design Assurance Engineer @ Boston Scientific Corp • Led design assurance for new product development leading to commercialization of four new products. • Developed quality plans, risk management files, and design verification protocols. • Performed validation of test methods, IQ/PQ/OQ, accelerated and real time aging, bio-compatibility, and sterilization. • Developed field assessment /post market vigilance plans. • Developed standard operating procedures in conformance with the QSR, ISO14971/13485, MDD, IEC 60601, and other regulatory standards.• Ensured procedure compliance with software regulations, risk management, and change control. From October 2004 to April 2012 (7 years 7 months) 150 Baytech Drive, San Jose, CASr. Product Assurance/ReliabilityEngineer @ Covidien • Developed protocols and plans for new ventilator product. Led regulatory and clinical affairs, safety compliance, and software QA. Generated test procedures and methods for design verification and validation. • Generated test processes and procedures. Setup test equipment, calibration, and periodic maintenance procedures. Prepared testing and failure analysis reports.• Managed reliability engineering and test laboratories and equipment maintenance. Predicted reliability using RelCal.• Performed operation/storage temperature cycling, mechanical shock/drop, vibration, stability, and electrical emission and immunity and reliability demonstration tests.• Analyzed test results and provided recommendations for reliability improvements. From June 2003 to October 2004 (1 year 5 months) Pleasanton, CASupplier Quality Engineering Manager @ Turnstone Systems Inc • Managed component engineering, test laboratories, and testing equipment. Developed component test plans and maintained test records. Created project budgets.• Managed, qualified, and audited component suppliers. Developed procedures for inspecting, testing, and evaluating components. Conducted site audits. Wrote audit reports and implemented corrective procedures.• Conducted audits of contract manufacturing facilities, suppliers and vendors in accordance with audit plans to ensure compliance with guidelines and procedures.• Identified Asian suppliers for antennas, flash memory modules, cables, and TNC connectors. Saved company more than $700,000 in manufacturing costs. • Established procedures for internal audits and prepared for ISO 9000 certification From October 1999 to June 2003 (3 years 9 months) Santa Clara, CASr. Product Assurance/Reliability Engineer @ Covidien • Developed reliability test plans for new product development. Performed tests on HALT/HASS, EMI/ESD, mechanical shock and vibration, temperature cycling, environment stress, and MTBF life demonstration. Created test procedures, test reports, and design validation summaries for FDA submissions.• Identified and evaluated product reliability problems. Initiated and provided solutions. Verified implementation of solutions. • Developed a reliability assessment plan for oximetry monitors and performed QA and Reliability verification at the DVT and Product Qualification stages.• Prepared technical files for CE marking and safety certification. From June 1995 to October 1999 (4 years 5 months) Pleasenton, CAMaufacuturing Engineer @ Johnson & Johnson • Led a three man-team, designing fixtures and wrote the test program. Resolved technical issues for production line. Developed troubleshooting procedures. Conducted training for manufacturing personnel for technical requirements• Played key role in yield improvement project. Used FMEA, SPC and DOE to increase the production yield from 95% to 97%. Developed rework troubleshooting guidelines for the manufacturing. Defined and implemented test process which resulted in $200,000 savings. From August 1989 to October 1995 (6 years 3 months) Milpitas, CAPrincipal Technical Manager @ Genetech · Completed Phase II Clinical Trial in the cGMP environment for a combination product development with a focus on process development, design verification, risk management, packaging, sterilization and validation. · Managed the CMO quality system and staff for meeting the project budget, schedule and deliverable and became a key contributor for lunching the clinical trial successfully.· Led cGMP audit, commissioning and de-commissioning and completed the Risk Management File including Risk Management Plan, Hazard Analysis and u/d/pFMEAs.· Generated Biocompatibility Test Protocol and Packaging Validation Protocol. From December 2014 to February 2017 (2 years 3 months) South San FranciscoIndependent Quality Consultant @ Medical Device and Biotech · Completed Risk Management File including Risk Management Plan, Hazard Analysis and u/d/pFMEAs.· Developed Design Control procedures and guidelines for the product development. · Generated the Quality System for startup companies.· Maintained the design history file. From 2012 to 2014 (2 years) San Francisco Bay Area