Stephanie K. Email
Director, QMS and Compliance @ Resilience
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Stephanie K. Location
- Alachua, FL, US
Stephanie K. Work
- Director, QMS and Compliance @ (December 2023 - Present)
- Head of Quality Strategy and Planning @ (June 2023 - January 2024)
- Lead, Quality Operational Excellence @ (August 2022 - June 2023)
- Senior Director of Quality Assurance @ (May 2019 - August 2022)
- Interim Head of Quality @ (May 2021 - October 2021)
- Director of Quality Assurance @ (January 2016 - May 2019)
- Sr. Quality Assurance Manager @ (January 2015 - January 2016)
- Quality Assurance Manager @ (December 2013 - January 2015)
- Director Quality Assurance and Regulatory Affairs @ Allograft Innovations, Inc. (March 2011 - July 2013)
- Tissue Bank Director and Chief Financial Officer @ Allograft Innovations, Inc. (November 2010 - March 2011)
- Donor Services Quality Manager @ (May 2007 - November 2010)
- Quality Systems Specialist - Audit Coordinator @ (August 2005 - May 2007)
- R and D Project Coordinator @ (June 2004 - August 2005)
- Research And Development Technician @ (March 2003 - June 2004)
- Veterinary Technician @ Affiliated Pet Emergency Services (October 2002 - April 2004)
- Veterinary Receptionist @ (June 2000 - April 2003)
- Laboratory Animal Technician @ (October 2001 - March 2002)
- Veterinary Technician @ (April 1999 - June 2000)
- Chiropractic Assistant @ (June 1998 - April 1999)
Stephanie K. Education
- Saint Leo University
Bachelor of Arts - BA (PSYCHOLOGY)
2006 - Santa Fe College
Associate of Arts - AA (PSYCHOLOGY)
2004
Stephanie K. Skills
- 510k
- Acquisition Integration
- Budget Management
- Call Center Administration
- Complaint Investigations
- Complaint Management
- Compliance Oversight
- Cross-functional Collaborations
- Cross-functional Coordination
- Cross-functional Team Leadership
- Cross-team Collaboration
- Data Analysis
- Design Transfer
- Document Management
- External Audits
- FDA GMP
- Failure Mode and Effects Analysis (FMEA)
- Financial Planning
- GAMP 5
- ISO 13485
- ISO 9001
- Internal Audits
- International Regulations
- Inventory Analysis
- Management Review
- Managing Project Budgets
- Manufacturing Process Improvement
- Medical Devices
- Medical Records
- Operational Excellence
- Operational Planning
- Planning Budgeting & Forecasting
- Process Optimization (Manufacturing)
- Product disposition
- Production Analysis
- Project Management
- Quality Auditing
- Quality Management
- Quality System
- Quality System Compliance
- Regulatory Affairs
- Regulatory Compliance
- Regulatory Submissions
- Strategic Communications
- Strategic Leadership
- Strategic Planning
- System Deployment
- Tissue Banking
- U.S. Food and Drug Administration (FDA)
- U.S. Title 21 CFR Part 11 Regulation
Stephanie K. Summary
- Stephanie K., based in Alachua, FL, US, is currently a Director, QMS and Compliance at Resilience. Stephanie K. brings experience from previous roles at Resilience. Stephanie K. holds a Bachelor of Arts - BA in PSYCHOLOGY @ Saint Leo University. With a robust skill set that includes 510k, Acquisition Integration, Budget Management, Call Center Administration, Complaint Investigations and more. Stephanie K. has 1 emails on RocketReach.
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