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Christine Day Location
Stoughton, MA, US
Christine Day Work
SVP of Global Quality Assurance and Regulatory Affairs @ (June 2025 - Present)
VP of Quality Assurance and Regulatory Affairs @ (February 2024 - June 2025)
Global VP of Quality Assurance and Regulatory Affairs @ (August 2021 - December 2023)
Senior Director of Global Supplier Quality and Change Control @ (January 2021 - July 2021)
Senior Director QA and RA-US @ (May 2016 - January 2021)
Senior Director of QA and RA-US North East @ (March 2014 - May 2016)
Director of Quality and Regulatory @ (April 2012 - February 2014)
Director of Quality Assurance and Document Control @ (September 2009 - April 2012)
Director of Quality Assurance and Document Control @ (October 2006 - August 2009)
Scientist @ Bayer Diagnostics (July 1999 - October 2006)
Christine Day Education
Simmons University
Bachelors (Biology & Chemistry)
1995-1999
Christine Day Skills
21 CFR
ASQ
ASQ Certified Lead Auditor
ASQ Certified Quality Manager
CAPA
CE marking
CQA
CQE
Certified Lead Auditor
Change Control
Complaint Management
Corrective and Preventive Action (CAPA)
Cross-functional Team Leadership
Design Control
Document Management
ETO and GAMMA Sterilization
FDA
FDA GMP
FMEA
Failure Mode and Effects Analysis (FMEA)
GMP
ISO 13485
ISO 13485, ISO 9001, 21CFR, MDD
ISO 14971
ISO 9000
International Regulations
Leadership
Management
Manufacturing
Medical Devices
Networking
Process Validation
Product Development
Quality Assurance
Quality Auditing
Quality Control
Quality System
Regulatory Affairs
Regulatory Approvals
Regulatory Submissions
SPC
Social Media
Social Networking
Statistical Process Control (SPC)
Sterilization
U.S. Food and Drug Administration (FDA)
V&V
Validation
Verification and Validation (V&V)
Verification And Validation V&V
Statistical Process Control Spc
Biotechnology
ISO 9001
Corrective And Preventive Action Capa
Cross Functional Team Leadership
U.S. Food And Drug Administration Fda
Failure Mode And Effects Analysis Fmea
Financial Analysis
Mdd
SQL
Pharmaceutical Industry
21Cfr
Failure Mode and Effects Analysis
Statistical Process Control
u.s. Food and Drug Administration
Verification and Validation
Corrective and Preventive Action
Christine Day Summary
Christine Day, based in Stoughton, MA, US, is currently a SVP of Global Quality Assurance and Regulatory Affairs at KARL STORZ. Christine Day brings experience from previous roles at KARL STORZ, Spectrum Plastics Group and Tecomet, Inc. Christine Day holds a 1995 - 1999 Bachelors in Biology & Chemistry @ Simmons University. With a robust skill set that includes 21 CFR, ASQ, ASQ Certified Lead Auditor, ASQ Certified Quality Manager, CAPA and more. Christine Day has 2 emails and 3 mobile phone numbers on RocketReach.
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