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Don Keren Location
Melrose, MA, US
Don Keren Work
Director Of Quality Assurance @ (April 2022 - Present)
Manager of Quality Assurance @ (September 2016 - April 2022)
Director Of Quality Assurance @ (February 2021 - December 2021)
Global Manager, Quality Systems @ (October 2018 - January 2021)
Pure Encapsulation @ (March 2016 - August 2016)
Director of Quality @ Rapid MicroBiosystems (October 2011 - December 2015)
Manager of Quality Assurance and Regulatory Affairs (US Operations) @ (September 2008 - September 2011)
Manager of Quality and Regulatory Affairs @ Genetix (January 2008 - January 2011)
Don Keren Skills
ISO 13485
Medical Devices
FDA
Quality Management
Regulatory Affairs
Lean Manufacturing
V&V
Design Control
R&D
Biotechnology
Technology Transfer
Validation
Hardware Diagnostics
Quality Assurance
CAPA
21 CFR Part 11
GMP
Change Control
Sop
GLP
ISO 14971
FDA GMP
Quality Auditing
Lifesciences
Quality System
GxP
Life Sciences
Integration
Customer Service
u.s. Food and Drug Administration Fda
Public Speaking
Leica
Operations
u.s. Food and Drug Administration
Don Keren Summary
Don Keren, based in Melrose, MA, US, is currently a Director Of Quality Assurance at Morphic Medical. Don Keren brings experience from previous roles at Vascular Insights, LLC, LaunchWorks CDMO, Haemonetics and Pure Encapsulations. With a robust skill set that includes ISO 13485, Medical Devices, FDA, Quality Management, Regulatory Affairs and more. Don Keren has 1 emails and 2 mobile phone numbers on RocketReach.
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