Stacy Sanford
Minnesota State College Southeast
Tell me more about Stacy Sanford?
Stacy Sanford is a highly experienced Quality System professional with 23.9 years of work experience. She specializes in implementing software, processes, and procedures based on regulatory requirements and standards. Stacy has expertise in FDA regulations, quality assurance, medical devices, and CAPA. She is skilled in internal auditing, CAPA, field actions, complaint handling, regulatory reporting, and product evaluation. Stacy has worked at Nextern and Monteris Medical, where she held various quality systems management and engineering roles. She is known for her ability to meet deadlines and thrive in deadline-driven environments.
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About
Quality System professional specifically focused on configuration and implementation of software, processes and procedures based on regulatory requirements, standards, and continuous improvement. Development of reporting tools for accurate, professional, and timely reports of trending data. Internal auditing in accordance with FDA and ISO 13485:2016 regulations utilizing MDSAP audit approach. CAPA, Field Actions, Complaint Handling, regulatory reporting, and product evaluation. Poised and competent with demonstrated ability to meet immediate deadlines. Thrive in deadline-driven environments.
...See MoreWork Experience
global quality systems manager at nextern
Medical Equipment Manufacturing
Stacy Sanford's Professional Milestones
- Sr. Post Market Quality Assurance Specialist (2006-07-01~2011-07-01): Implemented robust quality assurance processes, reducing defects and optimizing product excellence.
- Quality System Engineer (2018-05-01~2020-10-01): Implemented robust quality control measures, resulting in reduced defects and reduced defects.
Education
Nursing,
Associates,
Associate Of Arts
1995-1997Skill
Fda
Quality Assurance
Medical Devices
Capa
Quality System
Iso 14971
Iso 13485
Reporting And Analysis
Software Documentation
Quality Auditing
Design Control
V&v
Complaint Management
Regulatory Affairs
Sop
Access
Validation
Gmp
Manufacturing
Six Sigma
Process Improvement
Root Cause Analysis
21 Cfr Part 11
Cross Functional Team Leadership
Change Control
Iso
Quality Management
Quality Control
Testing
Agile Project Management
Documentation
Quality Systems
Complaint Handling
Customer Focus
Vigilance Reporting
Medical Device Regulations
Document Management
Data Analysis
Internal Audit
Computer System Validation
Oracle Agile Plm
Taleo
Salesforce.com
Unique Device Identifier
Microsoft Power Bi
Fda Esubmitter
Certification
Colleagues
Michael Brenzel
Chief Technology Officer
Caroline Byrd
Vice President Regulatory Quality And Clinical
Wesley Omer
Chief Operations Officer
Oscar Eduardo Domingo Maldonado
site director site implementation manager & risk management process owner
Avinash Kumar
general manager -asia operations shenzhen china hcmc vietnam manufacturing medical devices
Other Named Stacy Sanford
Frequently asked questions
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Stacy Sanford works for Nextern
Stacy Sanford's role in Nextern is global quality systems manager at nextern
Stacy Sanford works in the industry of Medical Equipment Manufacturing
Stacy Sanford's colleagues are Michael Brenzel,Caroline Byrd,Wesley Omer
Stacy Sanford's latest job experience is global quality systems manager at nextern at Nextern
Stacy Sanford's latest education in Minnesota State College Southeast