Jake Hong

Jake Hong Email and Phone Number

Director，RA and QA @ MicroPort
Suzhou, CN
Jake Hong's Location
Suzhou, Jiangsu, China, China
Jake Hong's Contact Details

Jake Hong personal email

n/a
About Jake Hong

3 successful on-site FDA inspections (One of the most strictest audits/inspections in the world)17-year Quality Management experience; 15-year Medical Device QA&RA Leadership; 15-year ISO & CE Audits; 13-year NMPA on-site Inspections;11-year NMPA product registration work experience;10-year NMPA affair compliance events;15-year staff management experience；PMP Qualification.

Jake Hong's Current Company Details
MicroPort

Microport

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Director，RA and QA
Suzhou, CN
Jake Hong Work Experience Details
  • Microport
    Director，Ra And Qa
    Microport
    Suzhou, Cn
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  • Microport
    Director，Ra&Qa
    Microport Dec 2018 - Present
    Shanghai & Suzhou
    Director,RA&QA for four Legal EntitiesCover DC , R&D, Manufacturing； GMP & GSP
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  • Spacelabs Healthcare
    Ra&Qa Manager, Apac
    Spacelabs Healthcare Dec 2017 - Oct 2018
    Suzhou Shanghai
    Suzhou Manufacturing site leaderEstablish and maintain Quality Management System in Suzhou facilityEstablish and maintain GSP Quality Management System in Shanghai office, customer service centers & warehousesAchieve CFDA MD Product Licenses for Imported and Domestic medical devicesRegister MDs and achieve the sales permits of MDs to all the countries in Asia-Pacific areaSupport marketing on the marketing planSupport and monitor the customer service activitiesHandle all CFDA issues: Adverse Events, Recall, Wrong label, etc
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  • Invacare Corporation
    Plant Quality Manager
    Invacare Corporation Mar 2014 - Sep 2017
    Sip, Suzhou, China
    Maintain and re-register the CFDA Medical Device Product Licenses;Maintain Quality Management System;Lead the routing review on QMS procedures;Work with DNV(Third-Party Notified Body) to maintain CE(MDD) certificates and ISO 13485 Certificate;Leader for CFDA Audits& FDA inspection, Notify Body Audits(ISO&MDD), Customer Audits & Internal Audits (including corporate internal audits).Lead the reply on findings/nonconformance from the audit/inspectionDaily quality control managementCustomer Complaints & Daily Quality Non-conformance via NC and CAPA management system;Host the Quality, Customer Complaint, CRB, MRB meetings;Design Control via Change Control Board (CCC);Internal Tutor of FDA QSR (21 CFR Part 820), CFDA GMP, ISO13485, CE, etc;Quality Resp. in Lean Manufacturing Projects; Process Validations' review and approval;Maintain the Production and Sales Licenses；
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  • Invacare Corporation
    Ra Manager, Great China
    Invacare Corporation Oct 2010 - Mar 2014
    Acquire and maintain the CFDA Medical Device Product Licenses;Maintain the Production and Distribution Licenses；Organize seminars with CFDA officers to maintain the good relationship;Maintain Quality Management System:Work with DNV(Third-Party Notified Body) to maintain CE(MDD) certificates and ISO 13485 Certificate;Monitor and make the operation meet the requirement of FDA;Handle customer complaints;Initiate Repairing Center for China Market;Design Control via Change Control Board (CCC);Quality Resp. in new projects;Internal Tutor of FDA QSR (21 CFR Part 820), ISO13485, CE, etc.Leader for CFDA, FDA Audits, Notify Body Audits(ISO&MDD), Customer Audits & Internal Audits (including corporate internal audits).Patent, Trade-mark, CCC, CQC, Product bar-code, etc.
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  • Invacare Corporation
    Asst. Quality Manager
    Invacare Corporation Oct 2004 - Oct 2010
    Suzhou
    Establish and maintain the Quality Measurement Lab.Handle all Quality Non-conformance, including incoming, process, outgoing and customer complaints; Host quality and customer complaint meetings;Quality Resp. in new projects, initiate and maintain the PFMEA and Control Plans;Calibration Management on test & measurement equipment (TME);Establish and maintain the Quality Management System;Internal audits and external audits, including ISO13485, ETL, TUV, FDA，CFDA, etc;PPAPs' Review and approval;Design Control: Participate in CCB (Change Control Board). Initiate, review and approve ECR/ECN;
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  • 华硕
    Mqc Engineer
    华硕 Feb 2003 - Oct 2004
    Suzhou
    Establish and maintain Incoming inspection proceduresNon-conformance in incoming & process Supplier process & System auditMonitor suppliers' Quality status and Continuous Improvement Project (CIP) with suppliersTeam Leader of Quality Control Cycle (QCC)
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Jake Hong Skills

Quality Management Fda Medical Devices Iso 13485 Quality System Capa Lean Projects Tqm Dmaic Msa Ppap Apqp Doe Spc Pmea Iso 14971 Mdd Qsit

Jake Hong Education Details

Frequently Asked Questions about Jake Hong

What company does Jake Hong work for?

Jake Hong works for Microport

What is Jake Hong's role at the current company?

Jake Hong's current role is Director，RA and QA.

What is Jake Hong's email address?

Jake Hong's email address is jh****@****are.com

What schools did Jake Hong attend?

Jake Hong attended North University Of China.

What skills is Jake Hong known for?

Jake Hong has skills like Quality Management, Fda, Medical Devices, Iso 13485, Quality System, Capa, Lean Projects, Tqm, Dmaic, Msa, Ppap, Apqp.

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