John T Kang is a eficient expert, working in Medtech Qa & Ra Consulting on the position of Qa and Ra Consultant since 2018. John T Kang gained professional experience in more than 11 positions at different companies. John T Kang went to the Boston University and was studying. Millbrae, California is the area, where this expert was known to settle. The person's e-mail and phone can be easily accessed through SoftwareOfficial by request.
Name variants:
Johnn Kang,
Jon Kang,
Jack Kang,
Jackie Kang,
Jacky Kang,
Johnny Kang
Last updated May 27, 2024
Contact Information
Last Update
Jul 7, 2022
Email
j_**@yahoo.com, jo**@swedish.org, jt**@hotmail.com
Location
Millbrae, CA
Company
Medtech Qa & Ra Consulting
Workplace
Qa and Ra Consultant
Work History
Senior Director, Regulatory Affairs and Quality Assurance
2825 Airview Blvd, Kalamazoo, MI 49002
Formerly Invuity and acquired by Stryker (2018). Oversee RA & QA functions and Management Representative. Addressed Remedial Actions with the FDA Prepare, coordinate and/or review 510(K) su...
Oct 2012 — Nov 2018
Senior Director, Quality Assurance
125 Shoreway Rd SUITE D, San Carlos, CA 94070
Formerly Hansen Medical acquired by Auris Health (2016). Head of Quality and Management Representative. Host External Audits.
Manage MDR Committee for regulatory reporting.
Review and app...
Mar 2011 — Dec 2012
Director of Regulatory Affairs and Quality Assurance
444 De Haro St, San Francisco, CA 94107
Head of Quality & Regulatory and Management Representative. Set Corporate Quality objectives. Responsible for FDB registration, FDA annual registration, Device Listings. Successfully impleme...
Feb 2009 — Sep 2011
Senior Manager, Regulatory Affairs and Quality Assurance
1615 Wyatt Dr, Santa Clara, CA 95054
Head of QA/RA. Responsible for all aspects of Quality Systems and Regulatory submissions. Management Representative. Hosted FDB, FDA & Notified Body audits. Responsible for company registrat...
Jul 2007 — Feb 2009
Post Market Qa Manager
250 Campus Dr, Marlborough, MA 01752
Former Cytyc Surgical. Managed all aspects of Post Market Monitoring. Responsible for all complaint assessments. Managed Safety Committee for regulatory agency reporting. Implemented correct...
Aug 2006 — Jun 2007
Clinical Quality Engineering Manager
455 Msn Bay Blvd, South San Francisco, CA
2001 - Complaint Manager and Clinical Trial Trainer Managed all complaints for clinical trials and responsible for clincial reports in Drug/Device combo studies. Provided physician training ...
Oct 2001 — Aug 2006
Quality Compliance Supervisor - Guidant Corporation
100 Boston Scientific Way, Marlborough, MA 01752
Manage Post Market surveillance activities - complaints, MDRs, Vigilance reporting. Facilitated world wide recall. Experience and appearance in Federal Grand Jury hearing with multiple depo...
Jul 1999 — Sep 2001
Senior Qa Compliance Specialist
3420 Central Expy, Santa Clara, CA 95050
Review and approval of Software Validations,
Facilitated software bug committee and software/hardware patch launches
Performed Internal and supplier Audits,
Supervised in-coming inspecti...
Jul 1998 — Jul 1999
Document Control Specialist
Supervised all Document Control activities,
Implemented and validated electronic document management system
Commercial readiness to support scalability
Batch production control and final...
Jul 1997 — Jul 1998
Occupations
Counselor
Executive
Senior Director
IT Professional
Software Tester
Representative
Waiter
Host
Advisor
Senior Manager
Operations Manager
Computer Specialist
Skills
San
Clariion
Storage
Brocade
Symmetrix
Vmware
Cisco Technologies
Dmx
Vmware Infrastructure
System Deployment
Vmware Esx
High Availability
Hardware
Nas
Storage Area Networks
Netapp
Process Improvement
Quality Management
Six Sigma
Design Control
Sterilization Validation
Packaging Validation
Risk Management
Mdr and Vigilance
510 K
Ctd
Pma
Clinical Training
Post Market Surveillance
Establishment Registration
International Product Registration
Document Management
Lean Manufacturing
Research and Development
Iec 60601
Regulatory Affairs
Medical Devices
V&V
Fda
Quality Control
Quality Assurance
Quality Auditing
Iso 13485
Quality System
Validation
Capa
Pharmaceutical Packaging
Sterilization
R&D
Product Development
Regulatory Submissions
Iso 14971
Regulatory Requirements
21 Cfr Part 11
Gmp
Sop
Change Control
Biotechnology
Clinical Trials
Gxp
Ce Marking
Medical Device Directive
Glp
U.s. Food and Drug Administration