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Rona Wu

Principal Quality Engineer

Design Control and Quality Consultant

Santa Clara, California

Section title

Rona Wu's Email Addresses & Phone Numbers

Rona Wu's Work Experience

Stryker

Principal Quality Engineer

February 2014 to December 2014

San Jose

Boston Scientific Corp

Principal Design Assurance Engineer

October 2004 to April 2012

150 Baytech Drive, San Jose, CA

Covidien

Sr. Product Assurance/ReliabilityEngineer

June 2003 to October 2004

Pleasanton, CA

Rona Wu's Education

Chongqing University

BS, Electrical Engineering

1978 to 1982

The University of Texas at Arlington

Master, Electrical Engineering

1986 to 1988

Rona Wu's Professional Skills Radar Chart

Based on our findings, Rona Wu is ...

Strong sense of self
Individualistic
Deep

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Based on our findings, Rona Wu is ...

56% Left Brained
44% Right Brained

Rona Wu's Estimated Salary Range

About Rona Wu's Current Company

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...

Frequently Asked Questions about Rona Wu

What company does Rona Wu work for?

Rona Wu works for Stryker


What is Rona Wu's role at Stryker?

Rona Wu is Principal Quality Engineer


What is Rona Wu's personal email address?

Rona Wu's personal email address is r****[email protected]


What is Rona Wu's business email address?

Rona Wu's business email addresses are not available


What is Rona Wu's Phone Number?

Rona Wu's phone (213) ***-*370


What industry does Rona Wu work in?

Rona Wu works in the Medical Devices industry.


About Rona Wu

📖 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


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In a nutshell

Rona Wu's Personality Type

Introversion (I), Intuition (N), Thinking (T), Judging (J)

Average Tenure

3 year(s), 6 month(s)

Rona Wu's Willingness to Change Jobs

Unlikely

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Rona Wu's Social Media Links

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