Simon Xiao

Leading a cross-functional value stream program to develop & deploy CCS (Contamination Control Strategy) in compliance with EU GMP Annex 1. Lead a team to achieve quality KPIs and assure cGMP compliance. Directly handling customer complaints, hosting customer, ISO and regulatory audits, overseeing customer specifications and quality agreements, as well as supplier quality Key Contributions: • Streamlined and optimized the processes of managing customer complaints and audit scheduling. • Developed a team with maturity and required problem solving skills. • Driving CAPAs for customer complaints, customer audit findings. • Supporting technology transfer, providing cGMP training, YBB regulatory compliance and new SKU creation. • Overseeing the product specifications, customer agreements and ensure correct SAP set-up for ROS/AQL, Test Suite & CoA (Certificates of Analysis). • Establishing the site contamination control plan with a pool of SOPs for compliance and implementation. • Spearheaded a project to have established the plant 5S program from scratch. • Led a lean six sigma project to have reduced the embedded contaminations by 30%. • Driving site quality culture to lay emphasis on customer focus, problem solving and continuous improvements with critical thinking mindsets, including organizing events of quality week, quality kaizen event. • Drafted the validation protocols and led the execution to have qualified the RU cleanrooms (ISO 7) for steam sterilization process in line with ISO 14644-1/2/3.

Achieved 50% reduction of customer complaints and 60% reduction of Cost of Non-Quality in two years through the realization of multiple lean six sigma projects including kaizen events, and effective 8D investigations. Customer facing quality lead with recognized 8D Problem Solving Practitioner and Coach accreditations. Currently working with both Airbus and Boeing build programs managing the operations quality performances to enable the whole engine assembly & test facility to provide the highest quality products and services to both internal and external customers, as well as driving continuous improvements to support supply chain stability and operational excellences. Supervising QMS for compliance and driving zero defect programs. Accountable for key quality KPIs including QMS audits, customer complaints, cost of poor quality, supplier quality notifications, testbed RTS and Quarantine Bond inventory (NCR).

Realised a lean six-sigma black belt project to have reduced the COPQ (cost of poor quality) for a key product line by 70% and reduced PPM by 60% in 2 years of time. Acted as a section manager of leading a team of 22 to meet overall quality performance of key products portfolio with annual revenue of US$240 million. Planned and managed resources for effective execution of corporate projects and diversified quality control operations including receiving, in-process and final inspections, CMM, hardness test, NDE, and Calibration. Led audits and APQ1 recertification. Formulated product quality control plans. Spearheaded projects across a range of functional activities, such as planning and logistics, risk management, supply chain management, cost control, productivity & efficiency, customer/supplier relationship management to assure continual improvements. Directed safety and lean manufacturing committees to assure compliance of ISO14001, and OHSAS 18001.

Developed and attained 17 critical suppliers to have captured US$18M of PPV annually. Led to have qualified 93 new products to have boosted shipment by 150% in two years. Successfully set up a New Product Development manufacturing facility in Singapore, using a budget of US$8M, supporting new product development/prototyping with the goals of enabling multiple design iterations for a given design cycle & optimizing design upfront to eliminate production learning curve. A leader of Supplier Management and Engineering Development of manufacturing processes. Responsible for sourcing strategy deployment, supplier development & qualification, auditing, and performance review. Led root cause analysis and drove corrective/preventive actions for major quality incidents. Facilitated training and prior lessons learned to internal and external parties. Prepared quotations for business bidding & conducted contract review. Managed daily engineering department activities including Process Routing, Fixtures, Tooling, CNC Programming, and First Article Qualification. Supervised the new products introduction and transfer. Developed QP (quality plan) and ITP (Inspection and Test Plan). Approved MTR, MPP, PPAP, PFMEA and FAI report. Created project charters, approved budgets, and managed Capex planning and risk mitigation.

Established a fresh sub-assembly test cell, deployed 27 fresh CNC machines, and engineered manufacturing processes for more than 100 aerospace components, led to a successful acceleration of the company manufacturing capacity by 300% and boosted shipment by 570% within three years. Prepared quotations for bids to support business development. Steered programmes for engineering feasibility study and contracts review, as well as controlled budgets. Acted as technical advisor to top management on business strategies establishment. Managed engineering activities including process planning, CNC programming/fixtures/ tooling preparation, and first article qualification. Resolved ECN amendments according to customer and regulatory requirements. Directed disposition of non-conformance parts.