Jerry Xiao

About Jerry Xiao

As a Quality Professional, I have been performing at a high level in the Medical Device industries more than ten years under the international standards of ISO 13485, 14971, 60601, 62304, 62366, FDA Title 21 part 820, QSR.* NPI (New Product Introduction): By means of working close with engineers, develop quality control points, quality requirements, and process maps to establish the quality assurance strategies in the design phase; participate the 3Q (Installation Qualification, Operational Qualification, and Performance Qualification); take charge of validation plans to make sure that the current process can produce the qualified products under any situation.* Risk management and Reliability Analysis. Build company risk policies, procedures, instructions, and forms; conduct XFMEA and FTA to identify the significant failure modes sufficiently, evaluate the factors of severity, occurrence, and detection; propose the recommendation actions until the significant risks are reduced within the tolerance. Develop reliability test plan, conduct reliability tests, predict and estimate the reliability parameters (MTTF.etc); setup preventive maintenance schedules and implement Design for Quality over time at the early stage.* Global Quality operations. Work with global quality team to manage material disposition; rank the weekly customer complaints and generate the reduction plans; monitor the change control to move ECRs on schedule; generate quality matrix and scoreboard to identify the barriers of the business success. Specialties: ASQ (American Society for Quality)* CQE (Certified Quality Engineer, No: 51325)* CSSBB (Certified Six Sigma Black Belt, No: 5410)* CQA (Certified Quality Auditor, No: 41321)* CRE (Certified Reliability Engineer, No: 7279)* ISO 13•••16 hours training certificate from STAT-A-MATRIX.* ISO 9001: 2008 32 hours internal auditor training from LT.

Experience

1. Quality Engineering Consultant

   Philips

   Jan 2025 — Present

   Philips Healthcare is a global medical technology company specializing in respiratory care, diagnostic imaging, patient monitoring, and connected health solutions.

Education

• Concordia University

  Master Degree, Quality System Engineering

Skills

• Fda
• Change Control
• Pdp (New Product Development Introduction)
• Iso 13485
• Quality System
• Quality Control
• Continuous Improvement
• U.s. Food and Drug Administration (Fda)
• Quality Assurance
• Risk Management
• Medical Devices
• Capa
• Iso 9000
• Systems Integration and Tests
• Product Development
• Design Control
• Validation
• Six Sigma
• Process Improvement