Song Yuan, Hendy Shi Email & Phone Number

Singapore

As the Quality Department Lead, I spearhead daily operational activities in collaboration with factory operations, drive new product innovation (NPI), and oversee the definition and implementation of ISO standards.Process Development: Established and implemented robust processes and tools to inspect and report quality issues effectively.Issue Resolution: Compiled, analyzed, and reported quality issues and defects to the production team, ensuring timely resolution.Data Management: Ensured systematic recording of quality issues to facilitate comprehensive data analysis and feedback to the production team.Quality Analysis: Conducted regular analysis of quality data to identify potential systemic issues and initiate product improvements.R&D Collaboration: Partnered with the R&D Department to conduct quality-related tests, supporting NPI.Cross-Functional Coordination: Worked closely with various departments and production teams to uphold product quality, manage costs, and ensure customer satisfaction.

Singapore, Singapore

Design, Development and Manufacturing of Mass Spectrometers and Liquid Chromatography for Medical and Research Use.• Provide Quality Engineering oversight for the design and development team and manufacturing team.• Conducting root cause analysis and implementing corrective action and completing effectiveness check on CAPAs.• Implementing lesson learned (retrospective) and early quality involvement, DFX activity• Developed and introduced Quality control plan and CTQ metrics for design and manufacturing.• Oversee the design and development of specific hardware and software products throughout realization, review and approve artifacts and development of Design History File (DHF) as per ISO-13485 and ISO-9001, FDA standards.• Participate in the review of product requirements and ensure proper and complete documentation of verification and validation processes and resulting records developed by other technical team members.

Singapore

Directed Quality and Reliability Design Verification Tests for Razer computer systems, peripherals, and merchandise, overseeing thorough system verification that included Mechanical, Electrical, Software, Safety, Regulatory, and EMC requirements.• Formulate comprehensive test strategies to ensure and meet quality standards for each new design qualification. • Draft meticulous Design Verification and Validation Plans and execute necessary testing, aligning with both Razer and industry standards, as well as adhering to the specified Design Requirements. • Proactively review RMA, customer returns, and social media comments, collaborating with RND EE/ME and Engineering to enhance test methods, preventing the recurrence of issues. • Facilitate improvements in in-line detection through collaboration with the Process team. • Effectively manage a team of ODM contractors and external test house activities, overseeing testing operations both locally and in China and Taiwan.

Singapore

Oversaw the Quality and Reliability Design Verification & Validation processes for Welch Allyn's Frontline Healthcare & Hill-Rom's Respiratory products, ensuring compliance with Mechanical, Electrical, Safety, Regulatory, and EMC requirements.• Formulated comprehensive test strategies ensuring quality assurance for each new design qualification. Created and executed Design Verification and Validation Plans based on applicable medical standards (e.g., IEC60601-1, IEC60601-1-2, 601-2-25, 601-2-51), Design Input Documentation, and Technical Reference Specification.• Orchestrated overall project management, leading the update of existing products to align with the latest regulatory requirements, showcasing commitment to regulatory compliance.• Served as the primary point of contact for RND EE/ME, overseeing test methods, equipment acquisition, sample plan definition, validation development, and regulatory/60601 requirements for electrical or mechanical design, EMC, and ME hazard requirements.• Demonstrated meticulousness in preparing and maintaining Design History Files (DHF) for projects. Tracked and drafted requirements, creating the Requirement Trace Matrix (RTM) for thorough project documentation.• Led discussions with RND, providing essential inputs for Corrective and Preventive Action (CAPA) activities. Represented RND in Factory Regulatory Audits and actively participated in internal/document audits for each project.• Managed a team of internal contractors and external test house activities, ensuring efficient coordination and execution of testing operations.• Provided crucial support for Clinical Trial activities and facilitated the setup of local test capabilities of IEC60601-2-51, bolstering design development at the Singapore RND office.

Singapore

Conducted Quality and Reliability Design Validation for Venture's Original Design & Manufacturing (ODM) products and sustaining engineering initiatives.• Managed the regulatory submittal process for Safety and EMC of ODM's products in accordance with IEC60950 and various country-specific requirements (e.g., UL, CSA, NOM, SPRING, CCC, TUV). Trained in UL60950 (ITE Product) and IEC60601 (Medical Product) standards.• Developed effective test strategies to ensure and meet quality standards for each new design qualification. Collaborated with customers to propose and discuss New Test Standards based on industrial available standards for new product development categories, such as Photo Developing Engine.• Oversaw test lab activities, including manpower allocation, cost budgeting, and controls for product validation within the groups. Actively participated in both internal quality audits and external regulatory audits.• Managed and validated a diverse range of products, including printers (Deskjet, Business Inkjet, 2nd Tray, etc.), photo developing machines, and medical devices.• Established and set up a printer test lab in Malaysia JB's new RND setup.• Led and trained a team of Engineers, Engineering Assistants, and Technicians (10-30 individuals) in qualification tests. Certified Internal Auditor of ISO9000 and ISO13485, with training in Risk Management ISO14971.• Acted as the liaison between suppliers and customers to address any quality issues encountered during reliability testing.

Singapore

Led resolution of critical customer issues, tracked and drove improvement in product and service performance, spearheaded Generic Issues Resolution in the Asia Pacific Region• Leading closed-loop resolution of critical customer issues, • Managing Customer Loyalty and Quality System Management programs to track and enhance product and service performance. • Spearheaded Generic Issues Resolution in the Asia Pacific Region and analyzed Customer Satisfaction Survey results for the same region.

Singapore

Managed setup and support for Audio-Visual IT products, infrastructure setup for regional support activities, conducted new product compatibility tests, provided troubleshooting, and conducted regional repair data analysis for product quality improvement.• Managed support setup for Audio-Visual IT products, including SONY's new products and VAIO (SONY new Notebook), across multiple countries in the Asia Pacific (excluding US, EU, and Japan).• Orchestrated infrastructure setup for regional support activities as a Technical Support Engineer.• Conducted New Product Compatibility tests for Audio-Visual IT products, specifically VAIO, with other potential products.• Provided troubleshooting for Audio-Visual IT products and VAIO (SONY new Notebook), addressing issues related to other products and operating systems (Win95/98/98SE, Win2000, etc.).• Conducted Quality Analysis, focusing on regional repair data analysis for continuous Product Quality Improvement.

Singapore

As a Manufacturing and Quality Engineer, sourced PCB assembly for ultrasound scanning instruments and kidney stone treatment machines, liaised with international counterparts for project transfers, conducted outgoing and incoming quality audits, and addressed supplier quality deviations in collaboration with RND.• Managed PCB assembly sourcing and collaborated with US counterparts for the project transfer of manufacturing ultrasound scanning instruments (Performa) in Singapore.• Oversaw PCB assembly sourcing and coordinated with German counterparts for manufacturing kidney stone treatment machines (Lithotripter) in Singapore.• Conducted outgoing quality audits, incoming quality checks for machined, assembly, and standard parts, and implemented in-process quality control for Lithotripter manufacturing as a Quality Engineer.• Led supplier quality audits, ensuring parts met specifications, and collaborated with RND to resolve any supplier challenges in meeting requirements.

Singapore

Led and trained a team in the Quality Assurance Department, overseeing Product Reliability Evaluation for audio, visual, and data products, including budget and manpower planning, drafting testing items with Japan's counterpart, conducting internal parts failure analysis, and providing support to Head Office, Japan, in the Design Stage Product Reliability Evaluation.

Master Of Technology (M.Tech.)

Bachelor Of Science