Experience

Solteam Medical _ Solteam Incorporation

• Quality Assurance Manager

  • Dec 2016 - Present

  Lead the QA/QC/SU team to implement the solteam's Medical QMS to meet the requirements of FDA QSR 21 CFR Part 820 and ISO 13485:2016 In charge of the following tasks: 1. Management representative (Ensuring that processes needed for QMS are documented; Reporting to the top management on the effectiveness of QMS and need for improvement; Ensuring the promotion of awareness of applicable regulatory requirements and QMS requirements throughout the organization) 2. QS Function(CAPA/customer complaint, change control, audit, regulation, DCC, training, QMS/QSR maintenance) 3. QA Function (Nonconformity, Supplier evaluation, project development, product release ) 4. QC Function (IQC, IPQC, FQC, QOC, metrology, DHR maintenance) 5. Scale up Function (Laboratory maintenance, verification protocol/report, calibration) Show less



Delta Electronics

• Taiwan
• Appliances, Electrical, and Electronics Manufacturing
• 700 & Above Employee

• QA Senior Section Manager

  • Sep 2011 - Nov 2016

  Manage QA unit (Taiwan and overseas factories) to achieve the following tasks,  System- 1. Deal with the production/system deviations and customer complaints 2. Manage the change control activities internally and review/inform customer’s 4M changes. 3. Responsible for the document release/control/reclcye of Document Control Center (DCC) 4. Responsible for the training of annual training plan/perform/maintain 5. Responsible for the equipment/instrument calibration management 6. Perform the internal and external audits and actions follow up 7. Hold the quality monthly meeting with customer and report the QMS effectiveness at the management review. 8. Participate in the audit including GMP (TFDA, CFDA, Russia government, Japan MHLW) , ISO 13485, and customer audits such as OMRON, J&J, Philips, Sanofi, SHT and so on.  Project- 1. Evaluate the DFq score card for new project per the DQA process. 2. Ensure the actions of past issues have been conducted into new projects. 3. Ensure the quality of samples before sending to the customers. 4. Control the project quality and ensure the DHF integrity per the Design and Development Process. 5. Prepare QA project documents and ensure the completed DMR before mass production. 6. Responsible for the IQC/IPQC/FQC/OQC 7. DHR Maintenance 8. Assist the mass productions projects transferring to overseas factories. Show less



National Open University

• Higher Education
• 1 - 100 Employee

• Lecturer

  • Feb 2006 - Feb 2012

  1、Computer and Life 2、Supplier Chain Management and Practices 3、Webpage Design Practices 4、Introduction to Computer Practice 5、Photoshop 6、Dreamweaver Dynamic Webpage Design 7、User-Friendly Interactive Design 8、Office Application Software Practices As the face-to-face teacher for the above courses. 1、Computer and Life 2、Supplier Chain Management and Practices 3、Webpage Design Practices 4、Introduction to Computer Practice 5、Photoshop 6、Dreamweaver Dynamic Webpage Design 7、User-Friendly Interactive Design 8、Office Application Software Practices As the face-to-face teacher for the above courses.



SHL Group (Scandianvian Health Limited)

• Quality Assurance Engineer

  • Oct 2005 - Sep 2011

   System- 1. Manage the change control activities internally and review/inform customer’s 4M changes. 2. Assist the investigation of NOD, CAPA and Complaints. 3. Participate in the audit including ISO 13485, and customer audits. 4. Train related personnel for quality courses.  Project- 1. Prepare QA project documents (quality assurance management plan, QAMP), purchase specification, packing working Instruction, label, COC, incoming inspection,in-process inspection, final inspection, out-going inspection) and ensure the completed DMR before mass production. 2. Participate in tooling trial shots and assembly validations and reviews reports 3. Participate in product development activities at Development phase 4. Assist in collecting/reviewing DHR in Mass Production phase. Show less



Inventec

• Taiwan
• Computer Hardware Manufacturing
• 700 & Above Employee

• Software Quality Assurance Engineer

  • Aug 2003 - Apr 2005

  1. Testing the system and accessories of notebooks (SIT/WAT) 2. Prepare testing plan for the projects. 1. Testing the system and accessories of notebooks (SIT/WAT) 2. Prepare testing plan for the projects.