Rue Wei Email & Phone Number

Vancouver, Wa, Us

Portland, Oregon Metropolitan Area

● Launched 11 products by leading key stakeholders and cross-functional teams through product development from concept to market. ● Expanded production capacity by 400% by working with contract manufacturers to streamline the manufacturing process, generating over $3.6 million in annual sales.● Acquired new suppliers for raw materials and components, resolving an urgent issue of a discontinued component for existing medical devices and reducing costs by 63%.● Increased yield from 75% to 97% by implementing new processes and materials in the lyophilization process, which eliminated recurring defects in the finished products.● Led an investigation into increased disposable filter usage, resulting in a 10% cost reduction for sub-assemblies.● Created testing plans and reports to support 510k submission, substantial changes to Medical Devices Directives (MDD), and Medical Device Regulation (MDR) submission in coordination with Regulatory team. ● Managed and developed design control documents throughout the medical device lifecycle, including design and development plans, design inputs and outputs, design reviews, technical protocols/reports, risk management plans/reports, and process FMEAs for gauze, bandage, and radial compression product lines.

Portland, Oregon Metropolitan Area

● Spearheaded quality and operations departments with contract manufacturers to streamline the manufacturing process and testing.● Developed medical devices with key stakeholders and cross-functional teams from concept to market including four successful product launches each within six-month timeframes. ● Managed design control documents throughout medical device lifecycles including generating design and development plans, design inputs and outputs, design review, and technical protocols/reports for product/material verification.● Qualified suppliers for new raw materials and components to optimize existing medical devices and save costs.● Performed internal audits and on-site supplier visits in support of CAPA and supplier qualification.● Optimized stability procedures and implemented a system to keep track of all stability testing activities.● Generated technical reviews and justification memos in support of CAPA and in-process changes. ● Identified gaps in quality system and collaborated with quality and regulatory departments to meet good documentation practices and regulations.

South Jordan, Utah, United States

● Creator of a new formula for a tooth whitening product (patent filed in August 2020; publication number 20210038358). ● Enhanced existing formulas for use in dental and teeth whitening products.● Reviewed and identified ingredients and requirements with suppliers for new products to be commercialized.● Performed stability and clinical studies on developed and enhanced formulas in comparison with competitor products to improve product quality and efficacy.● Led investigations on out-of-specifications products through root cause analysis and testing.● Developed R&D testing protocols and reports for stability, efficacy, safety, and clinical studies. ● Generated detailed chemical comparison matrices of major teeth whitening products in the U.S. for brand management through research and testing. ● Provided technical expertise to cross-functional teams for product improvement.● Led technical discussions on developing products between manufacturing and R&D departments.

Ogden, Utah, United States

● Led and executed multiple projects related to cost saving, purchasing, second supplier qualification, and validation of new materials.● Applied FDA/ISO Design Control regulations in material/supplier projects.● Conducted on-site supplier audits for supplier qualification projects according to ISO 13485 and cGMP (CFR 211). ● Developed project protocols, engineering reports, technical reports, operating procedures, design reviews and test methods to achieve cross-functional input and support.● Maintained good documentation practices for all data forms, protocols, engineering and feasibility reports and laboratory notebooks. ● Hands-on experience with fabrication and processing of peritoneal dialysis bags.● Trained production personnel on new processes and process changes.● Recommended and identified new materials and developed relationships with suppliers in close coordination with R&D, Regulatory, Quality System and Manufacturing Management.

Ogden, Ut

● Compiled insufficient audit finding responses by reviewing 3 years of supplier audits. ● Collaborated with quality department in out-of-specification investigations for dialyzers, peritoneal dialysis, and saline solutions products.

Ogden, Ut

● Reviewed design history files, research papers and internal reports on dialyzers, peritoneal dialysis, and saline solutions for the Risk Management Program in support of CAPA. ● Identified gaps in risk management documentation using post-production data and presented to quality management.