Please complete the CAPTCHA to continue
A concise factual answer block for searchers comparing this professional profile.
Yaling Chen is listed as Quality Engineering Principle Engineer at 瑞健醫療, a with 919 employees, based in Sanxia District, New Taipei City, Taiwan, Province of China. AeroLeads shows a matched LinkedIn profile for Yaling Chen.
Yaling Chen previously worked as Computerized System Validation Supervisor at Alvogen and RD Sr. Engineer (Team Leader) at Medeonbio. Yaling Chen holds 學士, Mechanical Engineering Related Technologies/Technicians from 國立交通大學.
This section adds company-level context without repeating Yaling Chen's masked contact details.
Review company-level records connected to Yaling Chen before choosing the right outreach path.
- Bachelor of Science in Mechanical Engineering- More than 10 years experience in medical device and pharmaceutical industry as role validation, RD and quality which covers the manufacturing knowledge of combination product, surgery device with catheter, capsule, tablet, etc.- Handle more than 30 products and the related validation activities, which covers semi/fully automatic production equipment, testing equipment/fixtures, metal component process, plastic tool process, printing process, assembly process, packing equipment, environmental system, etc.- Lifecycle management of medical device, equipment and computerized system- Familiar with ISO13485:2016, ISO9001:2015, ISO14971, risk management (FMEA), GAMP 5, MSA, etc.- Host internal/external training to improve the system or strengthen the team/group robustness.- Certified with ISO 13485:2016 Lead Auditor, ISO 9001:2015 Lead Auditor, Certificate of Quality Engineer (CQE), Certificate of Quality Technician (CQT), etc.- 30+ audit activities as auditee or auditor.
Company context helps verify the profile and gives searchers a useful next step.
A career timeline built from the work history available for this profile.
台灣 桃園市
• Manufacturing process developement, including system URS, DQ, FAT, SAT, IOPQ, p-FMEA, etc.• Product/Design transfer from engineering phase to mass production• Conduct/review the DHF & DMR of product and manufacturing system
台灣
• Handle whole’s site CSV projects and work with CSV team from other regions.• Establish CSV system, including procedure, templates, and internal trainings• Prepare, review and/or approve the CSV documents, which covers the IT infrastructure, IT applications (e.g., ERP, LIMS, EDMS, equipment lifecycle management system) and production/lab equipment.Success:• Conduct and handle the CSV of LIMS system to implement system successfully• Handle the CSV of IT Infrastructure to improve system efficiency• Improvement legacy systems (lab equipment, production equipment, inventory management system, etc.) to meet external inspection
台灣 臺北市
- Lead productive 3 persons' group to conduct validation activities to support product FDA approval- Build MSA and verification system, including procedure and template.- Based on user requirement, design (d-FMEA) and process (p-FMEA), establish the inspection plan, design verification plan and following test methods, including IQC, FQC, package test, transportation test, usability test, etc., and ensure the related international constrains are fulfilled.- Perform audit activity to vendor to strengthen the cooperation efficiency
台灣 桃園市
General Job Task• Handle more than 30 products and the related validation activities, which covers semi/fully automatic production equipment, testing equipment/fixtures, metal component process, plastic tool process, printing process, assembly process, packing equipment, environmental system, etc.• Generate and manage the risk management document (p-FMEA) for manufacturing process.• Deal the audit from customer side and support audit activity to vendor to strengthen the cooperation efficiencySpecial Task (Validation System Improvement):• Improve the verification and validation system of CSV according to ISPE GAMP5 to enhance the efficiency and decrease the risk and cost• Establish the procedure of test method development and verification procedure based on international guidance, ISO 11608-1, AIAG MSA, etc.• Regular department training to standardize and systemize VnV approach
Other employees you can reach at shl-medical.com. View company contacts for 919 employees →
羅偉綸
Colleague at 瑞健醫療New Taipei City, Taiwan, Province Of China
View →
AC
Annie Chen
Colleague at 瑞健醫療Taiwan, Province Of China
View →
賴
賴秋芬
Colleague at 瑞健醫療Taoyuan City, Taiwan, Province Of China
View →
PK
Per Klintenstedt
Colleague at 瑞健醫療Stockholm, Stockholm County, Sweden
View →
JC
Jillian Chong
Colleague at 瑞健醫療Taiwan, Province Of China
View →
王
王明舜
Colleague at 瑞健醫療Taiwan, Province Of China
View →
KM
Kuochen Mr. Lu
Colleague at 瑞健醫療Taoyuan City, Taiwan, Province Of China
View →
HC
Hsi Chih Chen
Colleague at 瑞健醫療Taiwan, Province Of China
View →
黃
黃飛凡
Colleague at 瑞健醫療Taipei, Taipei City, Taiwan, Province Of China
View →
AD
Andreea Dahl
Colleague at 瑞健醫療Stockholm, Stockholm County, Sweden
View →
Quick answers generated from the profile data available on this page.
Yaling Chen works for 瑞健醫療.
Yaling Chen is listed as Quality Engineering Principle Engineer at 瑞健醫療.
Yaling Chen is based in Sanxia District, New Taipei City, Taiwan, Province of China while working with 瑞健醫療.
Yaling Chen has worked for 瑞健醫療, Alvogen, Medeonbio, and 瑞健集團.
Yaling Chen's colleagues at 瑞健醫療 include 羅偉綸, Annie Chen, 賴秋芬, Per Klintenstedt, and Jillian Chong.
You can use AeroLeads to view verified contact signals for Yaling Chen at 瑞健醫療, including work email, phone, and LinkedIn data when available.
Yaling Chen holds 學士, Mechanical Engineering Related Technologies/Technicians from 國立交通大學.
Search by job title, company, industry, location, and seniority. Export verified B2B contact data when you need it.
Start free trial Search contactsCheck these profiles if this is not the Yaling Chen you were looking for.
