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.