Stefanie Koenig
Director of Quality and Regulatory at Vivify Health® | Lake Villa, Illinois, United States
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Stefanie Martinez Koenig serves as the Director of Quality and Regulatory at Vivify Health®, where she leverages over 20 years of extensive experience in Quality Assurance and Regulatory Affairs across diverse sectors, including medical devices, software as a medical device (SaMD), pharmaceuticals, and biopharma. In her current role, Stefanie is instrumental in establishing, implementing, and maintaining the Vivify Quality Management System and Design Control Process, ensuring compliance and excellence in product development for SaMD and its associated hardware. Her strategic leadership not only enhances product quality but also aligns with the company's commitment to delivering exceptional customer experiences.
As a key member of the executive leadership team, Stefanie collaborates closely with cross-functional partners throughout the Optum enterprise, fostering strong business partnerships that drive continuous improvement and innovation. Her expertise in Corrective and Preventive Actions (CAPA), manufacturing processes, and regulatory compliance enables her to create comprehensive, company-wide compliance solutions that meet both business and customer objectives within aggressive timelines. Additionally, her proficiency in languages, including Spanish, enhances her ability to engage with diverse teams and stakeholders, further enriching the collaborative environment at Vivify Health®.
Stefanie's passion for quality and regulatory excellence, combined with her results-driven approach, positions her as a pivotal figure in advancing Vivify Health®'s mission to improve healthcare delivery through innovative technology solutions. Her commitment to fostering a culture of quality not only ensures regulatory compliance but also enhances the overall effectiveness of the organization in meeting the evolving needs of the healthcare landscape.
Director of Quality and Regulatory at Vivify Health® in January 2023 to Present
Director of Clinical , Regulatory , and Quality at Bannick LLC, a primary device group in May 2021 to January 2023
Director of Quality Assurance & Regulatory Affairs at SOL-MILLENNIUM Medical Group in October 2019 to May 2021
Sr. Manager, Quality Assurance at Nypro, A Jabil Company in July 2018 to October 2019
Sr. Director Regulatory Affairs and Clinical Trials at LifeWatch in August 2016 to June 2018
Director of Quality Assurance at LifeWatch in February 2016 to August 2016
Director, Clinical Trials QA & RA at GE Healthcare in May 2011 to February 2016
Director QA /RA, Invasive Cardiology at GE Healthcare in March 2007 to May 2011
Assoc. Director, QA, RA & Training at Essential Group Inc. in July 2004 to March 2007
Sr. Manager, Quality Compliance Site Support & GMP Documentation at Pfizer (formerly Pharmacia) in June 2002 to June 2004
QA Manager, CAPA at Abbott Laboratories / Diagnostics Division in March 2000 to June 2002
Compliance Officer / CAPA Section Manager / Pharmaceutical Products Division at Abbott Laboratories / Diagnostics Division in March 2000 to March 2001
Supervisor Incoming Quality Assurance: / Pharmaceutical Products Division at Abbott Laboratories / Diagnostics Division in June 1999 to March 2000
Senior Quality Engineer; Chicago Distribution Center at Abbott Laboratories / Diagnostics Division in September 1997 to June 1999
R&D Product Developer / Quality Engineer at Abbott Laboratories / Diagnostics Division in June 1994 to September 1997
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FDA
Quality Auditing
CAPA
Quality System
Validation
GMP
Manufacturing
Software Documentation
Clinical Trials
Quality Assurance
Medical Devices
GxP
Global Regulatory Compliance
Laboratory
External Audit
Consent Decree
GLPs
Pharmaceutical Industry
ISO 14971
Regulatory Affairs
LIMS
Quality Control
Technology Transfer
21 CFR Part 11
R&D
Regulatory Requirements
Six Sigma
Clinical Development
CRO
ISO 13485
Design Control
Lifesciences
Change Control
Biotechnology
V&V
21 CFR
Regulatory Submissions
GLP
Sop
GCP
Pharmaceutics
Biopharmaceuticals
Quality Management
Cross-functional Team Leadership
Management
U.S. Food and Drug Administration (FDA)
Research and Development (R&D)
Corrective and Preventive Action (CAPA)
Spanish
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Discover more about Vivify Health®What is Stefanie Martinez Koenig email address?
Email Stefanie Martinez Koenig at [email protected] and [email protected]. This email is the most updated Stefanie Martinez Koenig's email found in 2026.
How to contact Stefanie Martinez Koenig?
To contact Stefanie Martinez Koenig send an email to [email protected] or [email protected]. (updated on January 08, 2024)
What company does Stefanie Koenig work for?
Stefanie Koenig works for Vivify Health®
What is Stefanie Koenig's role at Vivify Health®?
Stefanie Koenig is Director of Quality and Regulatory
What is Stefanie Koenig's Phone Number?
Stefanie Koenig's phone (217) ***-*436
What industry does Stefanie Koenig work in?
Stefanie Koenig works in the Medical Device industry.
Stefanie Koenig Email Addresses
Stefanie Koenig Phone Numbers
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