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Yi Chen Chen Email & Phone Number

CQA/CQS Sr. Engineer at Tymphany
Location: Taiwan, Province of China 4 work roles 2 schools
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Current company
Tymphany
Role
CQA/CQS Sr. Engineer
Location
Taiwan, Province of China
Company size
642 employees

Who is Yi Chen Chen? Overview

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Quick answer

Yi Chen Chen is listed as CQA/CQS Sr. Engineer at Tymphany, a with 642 employees, based in Taiwan, Province of China. AeroLeads shows a matched LinkedIn profile for Yi Chen Chen.

Yi Chen Chen previously worked as Regulatory Affairs at Kimforest and Quality/Regulatory Affairs Assistance Manager at Plexbio Co., Ltd.. Yi Chen Chen holds Molecular Biology from National Chung Hsing University.

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Email format at Tymphany

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Tymphany

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Profile bio

About Yi Chen Chen

 Over 8 years working experience at medical device QA/RA. Knowledgeable in QMS/GDP/ISO13485/Risk Management. Regulatory requirements (TFDA/EU IVDD). Effectively communication skills and team player.  Qualification: ISO 13485 Internal Auditor certified.

Current workplace

Yi Chen Chen's current company

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Tymphany
Tymphany
CQA/CQS Sr. Engineer
guangdong, china
Website
tymphany.com
Employees
642
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4 roles

Yi Chen Chen work experience

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Cqa/Cqs Sr. Engineer

Current
Tymphany

Taiwan

Apr 2023 - Present

Regulatory Affairs

Kimforest

。Create and Maintain GDP. 。Hold a Clinical Study and build the plan/report/change.。Prepare TFDA/FDA EUA registered documents .。Design IVD molecular diagnostic manufacturing factory.

May 2021 - Apr 2023

Quality/Regulatory Affairs Assistance Manager

Plexbio Co., Ltd.

。ISO 13485/GMP update, auditing, remediation of new scope and version.。Be lead auditor/auditee on internal/external/customer audit.。Host Management Review meeting. 。Contract review.。Internal QMS trainer.。Review/approve process and product documents。Apply TFDA Class I (Fluorescent Analyzer, Washing Processor) certificate.。Apply TFDA Class II (HCV Genotyping Kit) domestic certificate.。Contact for EU authorized representative.。Apply CE-IVD, FSC, and product registration (self-declared product).

Oct 2016 - May 2021

Qa Engineer

Plexbio Co., Ltd.

。Project QC/QA。Technical documents, risk management, and design review.。Nonconformity and complaint investigation and reply.。Change management hold.

Nov 2014 - Sep 2016
Team & coworkers

Colleagues at Tymphany

Other employees you can reach at tymphany.com. View company contacts for 642 employees →

SH Sasha Hui Sasha Hui Colleague at TymphanyShenzhen, Guangdong, China View → IM Igor Maxan Igor Maxan Colleague at TymphanyFrýdek-Místek, Moravia-Silesia, Czechia, Czech Republic View → WT Wei Tang Wei Tang Colleague at TymphanyDongguan, Guangdong, China View → BC Ben Chen Ben Chen Colleague at TymphanyChina View → AF Adrian Ferenc Adrian Ferenc Colleague at TymphanyKopřivnice, Moravia-Silesia, Czechia, Czech Republic View → 蒋 蒋忠云 蒋忠云 Colleague at TymphanyDongguan, Guangdong, China View → 林 林宏澤 林宏澤 Colleague at TymphanyTaiwan, Province Of China View → AX Alex Xie Alex Xie Colleague at TymphanyHuizhou, Guangdong, China View → BH Bill Hu Bill Hu Colleague at TymphanyGuangzhou, Guangdong, China View → SD Sebastiaan De Vries Sebastiaan De Vries Colleague at TymphanyShenzhen, Guangdong, China View →
2 education records

Yi Chen Chen education

FAQ

Frequently asked questions about Yi Chen Chen

Quick answers generated from the profile data available on this page.

What company does Yi Chen Chen work for?

Yi Chen Chen works for Tymphany.

What is Yi Chen Chen's role at Tymphany?

Yi Chen Chen is listed as CQA/CQS Sr. Engineer at Tymphany.

Where is Yi Chen Chen based?

Yi Chen Chen is based in Taiwan, Province of China while working with Tymphany.

What companies has Yi Chen Chen worked for?

Yi Chen Chen has worked for Tymphany, Kimforest, and Plexbio Co., Ltd..

Who are Yi Chen Chen's colleagues at Tymphany?

Yi Chen Chen's colleagues at Tymphany include Sasha Hui, Igor Maxan, Wei Tang, Ben Chen, and Adrian Ferenc.

How can I contact Yi Chen Chen?

You can use AeroLeads to view verified contact signals for Yi Chen Chen at Tymphany, including work email, phone, and LinkedIn data when available.

What schools did Yi Chen Chen attend?

Yi Chen Chen holds Molecular Biology from National Chung Hsing University.

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