Andrew Tan Keng Seang

1.Spearheaded the Quality Assurance department by providing strategic leadership to a 116-member department, including 6 direct reports. Governed the end-to-end quality lifecycle for Class II and Class III medical devices, encompassing product realization, document control, internal/external audit management, IQA, OQA and supplier quality engineering. Served as the designated Quality Management Representative (QMR) and Occupational, Health, and Safety (OHS) Management Representative ensuring plant-wide standard and regulatory compliance. 2.Define strategy and execution towards achieving Zero Defects, aggressively targeting the reduction of Cost of Poor Quality (CoPQ). Drove profitability and customer satisfaction by implementing stringent controls over scrap, rework, re-inspection and warranty claims, ensuring all products consistently meeting or exceeded customer and regulatory standards. 3.Championed cross-functional continuous improvement initiatives to elevate product and process excellence by analyzing key performance indicators—including First Pass Yield, DPPM and customer complaint rates. Led teams to identify root causes and implement robust corrective and preventive actions (CAPA) that significantly reduced reoccurrences and enhanced operational performance. 4.Directed the rigorous implementation of core quality frameworks, including Advanced Product Quality Planning (APQP), PFMEA and Control Plans to standardize best practices and mitigate product/process risks. Minimising high-stakes customer escalations, deploying resources decisively to protect customer relationships and ensure swift and effective resolution. 5.Governed the supplier quality management framework, establishing critical KPIs to drive compliance, mitigate supply chain risks and foster value-creating partnerships. Acted as the senior point of escalation for all critical material and supplier-related quality issues, ensuring rapid containment and resolution. 6.Cultivated a predictive, data-driven quality culture by mentoring teams in statistical analysis and problem-solving methodologies. Fostered a risk-based and predictive mindset to proactively identify and mitigate potential failures in a dynamic manufacturing environment, ensuring absolute traceability and disciplined non-conformance and quality control.

1.Led regional quality engineering team of 14 staffs in Malaysia and Ireland managing 4 manufacturing site overseeing design control, risk management and post-market surveillance for Class I, II & III medical devices - Urology, Tracheostomy, Respiratory and AEM products. Appointed as site's Person Responsible for Regulatory Compliance (PRRC). 2.Championed product quality and reliability through comprehensive design assurance program, implementing risk-based approaches for product/process design, transfer assessments, and risk-benefit analysis. Successfully represented quality engineering department in ISO13485, MDSAP, EU MDR, and SFDA audits. 3.Established regional technical leadership in quality engineering best practices, leading statistical analysis programs, Gage R&R implementation, and process capability studies throughout product lifecycle while driving proactive solutions for complex quality issues. 4.Directed cross-functional collaboration with R&D, Process Engineering, and Supply Chain to align project execution with quality, cost and schedule requirements. Developed comprehensive project quality plans for new product introductions, including determining risk management documentation requirements, resource allocation, scope and timeline management. 5.Governed design assurance requirements for new product development, including design input reviews, test method validation, technical specification reviews, and design verification/validation activities. Successfully implemented design control systems across multiple product lines. Led investigation and disposition of CAPAs, non-conformances, field safety corrective actions and change control & impact assessments. Developed and implemented effective quality management strategies that enhanced patient safety and customer satisfaction.

1.Led global process improvement initiatives for non-active medical devices, successfully implementing lean project management techniques that significantly reduced development timelines. Spearheaded program management for EU MDR 2017/745 regulation implementation across B. Braun Penang facility. 2.Established and managed global cross-functional strategic process assurance and compliance management team, coordinating quality management, regulatory affairs, medical scientific affairs, and global marketing to ensure comprehensive compliance strategies. 3.Developed and implemented company-wide material compliance management program, creating both long-term and short-term initiatives through strategic alignment with Supplier Quality Management, Global Regulatory Affairs and Medical Scientific Affairs departments. 4.Served as independent reviewer for design reviews, conducting comprehensive risk assessments and resolving complex dependencies throughout project lifecycles. Successfully minimized project impacts while ensuring compliance with EU MDR 2017/745, MDSAP and FDA regulatory requirements. 5.Led product cost optimization initiatives through COGS analysis and strategic quotation management, while facilitating effective communication between R&D, Quality Operations and manufacturing teams to maintain project milestones and regulatory compliance. R&D department representative and internal lead auditor for multiple regulatory bodies including ISO13485, MDSAP, Brazil Anvisa, Korean authority, Russian authority and major customer audits from Bayer, Novartis, and Merck, consistently achieving successful audit outcomes.

1.A lead role in developing and executing of standard operation procedures for Directive 2011/65/EU (ROHS II) compliance. Conducted the evaluation of RoHS compliant requirements in raw materials, manufacturing line compliance and product requirements. Conducted internal training for R&D, Manufacturing and Purchasing departments for Ambu worldwide (Mar to Jul 2014). 2.Successfully passed US FDA audit without any observations (FDA-483) for the medical device projects that I have managed. 3.Personally undergone two audits by notified body,BSI auditors (Nov 2012 and Dec 2014) and successfully proposed and implemented all action items to close all EU MDD 93/42/EE audit observations within a stipulated timeframe. 4.ISO13485, FDA QSR 21 CFR 820 and QMS ISO9001 auditing experiences - One of Ambu’s internal Lead auditors for 4 consecutive years (2013 to 2016), audited cleanroom manufacturing processes, automated surface electrodes manufacturing production line and quality control department. Conducted external audit on one of Ambu’s aScope – Laryngeal videoscope monitor manufacturer in Taiwan (April 2013). 5.Established and implemented the design verification plans based on new criteria in ISO standards and regulatory requirements for various needles (Subdermal and Concentric Needles) and surface electrodes (Neurology Cup and Wet Gel electrodes) to ensure all Design Input Requirements’ parameters were duly verified and documented. 6.Successfully assisted Ambu’s Regulator Affairs (RA) department for two product registrations (Ambu aScope3 and Ambu aScope monitor) in China by providing technical knowledge and product specification documentation to Beijing Institute of Medical Device Testing (BIMT) – May 2014.

1.Successfully lead and transferred 2 products and technologies from Nogales, Mexico and Florida, USA to Motorola Penang plant within a year by establishing headcount requirements for manufacturing, lean production line, utility setup, initial raw material acquisitions, comprehensive technical capabilities and best practice/knowledge transfer. 2.Effectively reduce tester/fixture conversion time through an intensive and easy to read tester/fixture conversion manual and proper hardware/software training to back-end maintenance technicians. 3.Continual collaboration with cross-functional groups such as technical operations, manufacturing and US R&D department on NPI and RMA board troubleshooting, timely implementation of new test hardware/software and correct release of new firmware & test application to the production. 4.Competent to offer value-added suggestions to upper management in terms of cost-saving projects, test/process cycle time reduction and test program & hardware improvements to improve test yield and minimize RTP (Re-Test Pass) issues. 5.Consistently able to juggle existing on-going NPI projects while managing day to day production issues on RTP / low yield / QA lot verification, troubleshoot tester related issues and test program optimization activities. 6.Successfully managed four external vendors (more than 30 headcounts) to support Motorola’s calibration and maintenance requirements that ensured no downtime and operating within the yearly budget.

1.Completed and analyzed ADNS-7050s wafer-to-package correlation and recommended wafer test optimization and test limit changes concerning product characteristics and wafer tester-to-package tester variations. 2.Work actively with the cross-functional group to solve / fine tune wafer test program and wafer fabrication process by tightening the ET parameter to improve and optimise the wafer process. As a result, the wafer test yields were increased by 40%. 3.Demonstrated a credible troubleshooting skill to conclude that wafer fabrication was the problem rather than IC design problem by taking into account test parameter setup, tester capability and temperature. 4.Provide technical support to Wafer Process Engineers in wafer process improvement/simplification, thus ensuring better die output, quality, process capability and electrical fault isolation. 5.Implement changes to improve existing wafer process/test program parameters through cpk and cp indexes of Six Sigma methodology implementations for continual quality improvements.