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Business Development @瑞福生醫 Reform Biomedicine Co., Ltd.
2022 ~ Present
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市場資訊幫助人選做職涯諮詢。 維護工程師 • 禹達工程有限公司職責:研發 / 安裝 / 銷售 / 維護 維護醫療器材的管理系統 ISO13485 / 第二等級醫療器材 (GMP) QMS:H5665。 負責向TFDA申請授權審查和 醫療器材 的查驗登記。 擔任客戶管理窗口,負責與醫生、護士長和
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國立臺灣海洋大學 National Taiwan Ocean University
System Engineering and Naval Architecture
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SMT課長、DIP課長 @信邦電子
2018 ~ Present
工程師、管理職。
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PowerPoint
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word
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4-6 years
國立陽明交通大學
工管所
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Sr. Supervisor - Production & planning @Natural Remedies Pvt.Ltd
2018 ~ 2020
Sr. Executive - Production & planning
More than one year
Problem Solving
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Leadership
Employed
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4-6 years
Madras University
Logistics and supply chain management
Avatar of Johnnychiang.
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Avatar of Johnnychiang.
Offline
Deputy Manager , Project Manager @Altek Corporation (Roche diabetes care the biggest supplier)
2013 ~ Present
Deputy Manager
More than one year
by simplify complicated questions , tracking status well and leading customer when they struggling to get excellent supplier evolution ranking report ,score is more then 90 alwaysPresented and demonstrated statement to Tier1 Glucose Meter VP in Launch meeting per 6 month. 4.Quality System Skill 4.1 Regulation : ISO13485,14971,15197 , Electronic Records; Electronic (ERES) , FDA part 820 and SWV model) 4.2 Leading Development Quality Assurance task : Failure mode and effect analysis (FMEA) , customer complaint handing (robust CAPA) , Validation , audit supplier , RoHS , Quality Plan , Training , system/SOP improved Senior Engineer For Glucose Meter Strip R
Illustrator
ISO13485
Process validation
Employed
Full-time / Interested in working remotely
6-10 years
National Defense Medical Center
Biochemistry

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More than one year
Deputy Manager, project manager
Logo of Altek Corporation (Roche diabetes care the biggest supplier).
Altek Corporation (Roche diabetes care the biggest supplier)
2013 ~ Present
Taiwan, 台灣
Professional Background
Current status
Employed
Job Search Progress
Professions
Project / Product Management
Fields of Employment
Home Care Services
Work experience
10-15 years work experience (6-10 years relevant)
Management
I've had experience in managing 1-5 people
Skills
Illustrator
ISO13485
Process validation
Quality Management System
AutoCad 2D
communcaited skill
6 sigma green belt
Languages
English
Fluent
Job search preferences
Positions
Deputy Manager
Job types
Full-time
Locations
Taiwan
Remote
Interested in working remotely
Freelance
Yes, I'm currently a full-time freelancer
Educations
School
National Defense Medical Center
Major
Biochemistry
Print

Johnnychiang

Deputy Manager, project manager


I am a Medical Device Project Management  who had experienced with Quality system (FDA part 820) , 6 Sigma Green Belt and R&D. Following is Launched product in Marketing.  

-Blood Glucose Meter,  (Class II)

-The smallest Insulin pump system (Class III)  2019第六屆國家產業創新獎  

-Endoscope (Class II)

-Ultrasonic image PCBA (Class II)

E-mail : [email protected]


Work experience

Deputy Manager , Project Manager and Quality Assurance

Altek Corporation  •  2013-July - Now

1.Achievement : 

1.1 Identified customer's spec/technical requirement and worked with Tier1 Glucose Meter in Germany/USA and Tier1 Endoscope in Demark to achieve total 12 products launched and success 600 times product improvement.The 12 average of products Gross profit is 20%.

1.2  Simplified technical quality issues by collecting problem , analyzing trouble-shooting approaches, and controlling  Logistic process to keep revenue 70 million USD  in 2020

1.3 Familiar with Medical Device regulation by Quality system experience that lead team did not go long way

2.Project Management 

2.1 Collaborated with  8 departments , stakeholder , supplier(Germany,Japan,China) and 1000 person Factory.It  evaluated R&D resource , Capacity and budget review to create additional revenue : 0.4 Million USD and Costing saving 0.84 Million USD in 2020.

2.2 . Analyzed Pros and Corns to team and then encouraged member to accelerated timeline (3-10%) in Engineer change projects. 

3.Customers’ trust

3.1 Solved customer's question by simplify complicated questions , tracking status well and leading customer when they struggling to get excellent supplier evolution ranking report ,score is more then 90 always .

3.2 Presented and demonstrated statement to Tier1 Glucose Meter VP in Launch meeting per 6 month.

4.Quality System Skill 

4.1 Regulation : ISO13485,14971,15197 ,  Electronic Records; Electronic (ERES) , FDA part 820 and  SW 62304 (V model) 

4.2 Leading Development Quality Assurance task  : Failure mode and effect analysis (FMEA) , customer complaint handing (robust CAPA)  , Validation , audit supplier , RoHS ,  Quality Plan , Training ,  system/SOP improved  

Senior Engineer For Glucose Meter Strip R&D

Delta Corporation  •  Jan-2011 - July-2013

  • Improve HCT range by design around for state-of-the-art Glucose Meter technical 
  • Provided Clinical trial test result for RA team submission FDA .
  • Led and Solved  product and technical issue by production line trouble-shooting that Co-work with Omron which is biggest "Blood Pressure Meter" company.

Engineer For Glucose Meter Strip R&D

HMD  •  Jan-2010 - Dec-2010

  • Maintain production line shipped by Glucose and Cholesterol  strip principle
  • Research Metal material for Cholesterol strip independently. 

Sales

Weimingpharma  •  Arp-2009 - Dec-2009

  • Visited pharma manufactured for API , Excipient of Product Compatibility . 
  • Maintained database of customer data ,quotation record, price list 
  • Monitored inventory level.


Skill

Marketing 


  • Competitor analysis: CGM/BGM
  •  Market size analysis

  • Quality function Deployment

Project Management 


  • Logistic and budget analysis
  • Cross function communication
  • Program Management 
  • PMBOK for change management
  • communication with Customer independently 

R&D


  • 6 Sigma Green Belt
  • Electrochemistry for Glucose strip
  • Root cause analysis
  • Kinetics of Enzymes 

Education


National Defense Medical Center

Master degree of Biochemistry

2005 - 2007

Feng Chia University

Bachelor degree of Environmental Engineer

1999 - 2003

Resume
Profile

Johnnychiang

Deputy Manager, project manager


I am a Medical Device Project Management  who had experienced with Quality system (FDA part 820) , 6 Sigma Green Belt and R&D. Following is Launched product in Marketing.  

-Blood Glucose Meter,  (Class II)

-The smallest Insulin pump system (Class III)  2019第六屆國家產業創新獎  

-Endoscope (Class II)

-Ultrasonic image PCBA (Class II)

E-mail : [email protected]


Work experience

Deputy Manager , Project Manager and Quality Assurance

Altek Corporation  •  2013-July - Now

1.Achievement : 

1.1 Identified customer's spec/technical requirement and worked with Tier1 Glucose Meter in Germany/USA and Tier1 Endoscope in Demark to achieve total 12 products launched and success 600 times product improvement.The 12 average of products Gross profit is 20%.

1.2  Simplified technical quality issues by collecting problem , analyzing trouble-shooting approaches, and controlling  Logistic process to keep revenue 70 million USD  in 2020

1.3 Familiar with Medical Device regulation by Quality system experience that lead team did not go long way

2.Project Management 

2.1 Collaborated with  8 departments , stakeholder , supplier(Germany,Japan,China) and 1000 person Factory.It  evaluated R&D resource , Capacity and budget review to create additional revenue : 0.4 Million USD and Costing saving 0.84 Million USD in 2020.

2.2 . Analyzed Pros and Corns to team and then encouraged member to accelerated timeline (3-10%) in Engineer change projects. 

3.Customers’ trust

3.1 Solved customer's question by simplify complicated questions , tracking status well and leading customer when they struggling to get excellent supplier evolution ranking report ,score is more then 90 always .

3.2 Presented and demonstrated statement to Tier1 Glucose Meter VP in Launch meeting per 6 month.

4.Quality System Skill 

4.1 Regulation : ISO13485,14971,15197 ,  Electronic Records; Electronic (ERES) , FDA part 820 and  SW 62304 (V model) 

4.2 Leading Development Quality Assurance task  : Failure mode and effect analysis (FMEA) , customer complaint handing (robust CAPA)  , Validation , audit supplier , RoHS ,  Quality Plan , Training ,  system/SOP improved  

Senior Engineer For Glucose Meter Strip R&D

Delta Corporation  •  Jan-2011 - July-2013

  • Improve HCT range by design around for state-of-the-art Glucose Meter technical 
  • Provided Clinical trial test result for RA team submission FDA .
  • Led and Solved  product and technical issue by production line trouble-shooting that Co-work with Omron which is biggest "Blood Pressure Meter" company.

Engineer For Glucose Meter Strip R&D

HMD  •  Jan-2010 - Dec-2010

  • Maintain production line shipped by Glucose and Cholesterol  strip principle
  • Research Metal material for Cholesterol strip independently. 

Sales

Weimingpharma  •  Arp-2009 - Dec-2009

  • Visited pharma manufactured for API , Excipient of Product Compatibility . 
  • Maintained database of customer data ,quotation record, price list 
  • Monitored inventory level.


Skill

Marketing 


  • Competitor analysis: CGM/BGM
  •  Market size analysis

  • Quality function Deployment

Project Management 


  • Logistic and budget analysis
  • Cross function communication
  • Program Management 
  • PMBOK for change management
  • communication with Customer independently 

R&D


  • 6 Sigma Green Belt
  • Electrochemistry for Glucose strip
  • Root cause analysis
  • Kinetics of Enzymes 

Education


National Defense Medical Center

Master degree of Biochemistry

2005 - 2007

Feng Chia University

Bachelor degree of Environmental Engineer

1999 - 2003