David Lu
Senior Quality Assurance Engineer at Melten Inc.- Claim this Profile
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Bio
Credentials
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13485內部稽核人員
DNV GLApr, 2019- Oct, 2024 -
甲種職業安全衛生業務主管訓練
中國勞工安全衛生管理學會Apr, 2019- Oct, 2024 -
ISO 9001量規儀器校正與管理實務
科建顧問Mar, 2019- Oct, 2024 -
Six Sigma Green Belt
俐鉅創新管理顧問股份有限公司Apr, 2014- Oct, 2024 -
Six Sigma Green Belt
中華民國品質學會Mar, 2013- Oct, 2024 -
TAF17025實驗室人員
財團法人全國認證基金會Apr, 2012- Oct, 2024 -
CQT結業證書
科建管理顧問有險公司Jun, 2004- Oct, 2024 -
一般勞工安全衛生（營造，裝修）
中華民國海洋事業安全發展協會
Experience
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Melten Inc.
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Taiwan
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Medical Practices
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1 - 100 Employee
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Senior Quality Assurance Engineer
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Aug 2017 - Present
1. New project development time management management and provide relevant regulatory safety requirements verification information. 2. Product development and design change control and product development document review 3. Risk assessment and failure analysis and investigation of new and old products. 4. Supplier quality improvement plan processing. 5. IEC specification and verification plan & EMC related test and verification plan 6.ISO13485 import and plan the relevant processes of each department, and obtain evidence. 7. Plan internal annual audit planning and execution. 8. Annual instrument validation plan to write and complete validation and set acceptance criteria. 9. Management of quality control related work (IQC, OQC, IPQC) 10. Import GRR treatment tool acceptance criteria. 11.ISO13485 file management. 12. Manage RMA related jobs. 13. Test of IEC60601-1 verification specification. Show less
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New Deantronics
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United States
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Medical Equipment Manufacturing
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1 - 100 Employee
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Design Quality Engineer
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Mar 2013 - Jul 2016
Working Experience -New product quality management of Design Development. -Product Development and Design Change Control. -Provided regulation and safety requirement related for new product introduction -Risk assessment and management. Working Experience -New product quality management of Design Development. -Product Development and Design Change Control. -Provided regulation and safety requirement related for new product introduction -Risk assessment and management.
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FineTek Co., Ltd.
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Taiwan
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Automation Machinery Manufacturing
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1 - 100 Employee
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Deputy Section Manager of Quality
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Jun 2007 - Apr 2012
1. Write testing the project and plan. 2. Reliability identification and acceptance. 3. Function test and training. 4. Safety test and training. 5. Disturbance tolerance test and training. 6. Environmental Test and training.. 7. First production control tracking import. 8. Supplier Management and Audit. 9. Product ship certification test application. 10. Resistance to life test fixture development and design. 11. Respondent handling. 12. Establishment of RMA Group 8D report writing. 13. Set IQC, IPQC, OQC, FQC test benchmarks. 14.QA, QC staff annual education and training. 15.SPC analysis control. 16. Supplier management. 17. Standardization of inspection specifications. Show less
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Senao Networks
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Taiwan
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Telecommunications
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100 - 200 Employee
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Quality Assurance Engineer
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Apr 2003 - Jun 2007
1.IQC, IPQC, FQC, QE, QA. 2.Precision testing of parts. 3.Reliability test. 4.Part certification. 5.New Project Verification. 6.Electrical Test 7.Function Test 8.Software Test 9.Performance Test 10.Environment Test. 1.IQC, IPQC, FQC, QE, QA. 2.Precision testing of parts. 3.Reliability test. 4.Part certification. 5.New Project Verification. 6.Electrical Test 7.Function Test 8.Software Test 9.Performance Test 10.Environment Test.
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Education
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2002 - 2004
臺北城市科技大學
學士, 電機工程學系
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