Keisha Trippett-Sandle
Seagoville,TX
Summary
Highly experienced and results-driven Senior Quality Manager with over 25 years in quality systems, regulatory affairs, and customer feedback management. Exceptional ability to lead cross-functional teams, implement process improvements, and ensure compliance with global quality standards. Proven track record in reducing defect rates, enhancing product quality, and driving continuous improvement initiatives. Insightful Manager with experience directing and improving operations through effective employee motivational strategies and strong policy enforcement. Talented leader with analytical approach to business planning and day-to-day problem-solving.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Customer Feedback Manager
ARGON Medical Devices
04.2022 - Current
- Directed planning, preparation, and submission of MDR Vigilance and other regulatory reports globally, ensuring timely and accurate compliance.
- Managed root cause analysis investigations, determining underlying issues in product failures and implementing corrective actions as necessary.
- Participated in internal and external quality audits.
- Facilitated cross-functional team collaboration, ensuring seamless communication between departments regarding quality matters.
- Mentored and encouraged employees to strive for excellence while fostering professional growth.
- Updated quality control standards, methods, and procedures to meet compliance requirements.
- Improved quality processes for increased efficiency and effectiveness.
- Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.
- Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
- Cross-trained existing employees to maximize team agility and performance.
- Developed and maintained relationships with customers and suppliers through account development.
- Developed company culture focused on employee engagement, collaboration, and continuous learning opportunities.
- Achieved departmental goals by developing and executing strategic plans and performance metrics.
- Built high-performing teams through effective recruitment, onboarding, and talent development initiatives.
- Reduced operational costs through comprehensive process improvement initiatives and resource management.
- Organized professional development programs for staff, leading to improved performance and skill sets.
Regulatory Affairs Lead I
CTL Medical Corp.
06.2018 - 04.2022
- Spearheaded regulatory submissions and approvals for orthopedic devices, achieving successful clearances with FDA, ANVISA, EU, TUV, and TFDA.
- Conducted thorough reviews of labeling content for accuracy and adherence to relevant regulations before submission to authorities.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Recommended improvements to processes.
- Prioritized project-related tasks to efficiently complete essential tasks.
- Led product teams of 3-5 for regulatory product compliance.
Research Technician Crystalline Polymers
Solvay Specialty Polymers
04.2014 - 12.2016
- Executed complex experiments and tested various polymer formulations, delivering accurate and reliable data to support product development.
- Eliminated procedure gaps by effectively guiding and teaching Technicians on operations of machinery, inspection protocols and processes.
Quality Coordinator Government Affairs
General Dynamics
10.2012 - 04.2014
- Conducted intricate experiments and testing on polymer formulations, providing valuable insights for quality improvements.
- Managed customer complaints efficiently, resolving issues promptly while minimizing negative impact on business operations.
- Developed culture of continuous improvement within organization by encouraging team members to identify opportunities for enhancement and facilitating their efforts to implement those changes.
- Analyzed data trends to identify opportunities for process improvements, leading to more efficient workflow and higher quality output.
Quality Control Technician
BWay Corporation
02.2009 - 07.2012
- Led team of 11 associates in conducting routine quality checks, achieving a 15% increase in customer satisfaction through rigorous standards adherence.
Skills
- Quality Management Systems (QMS)
- Regulatory Submissions and Compliance
- CAPA System Implementation
- Customer Relations and Satisfaction
- Root Cause Analysis
- Process Improvement
- Supplier Quality Management
- Leadership and Team Management
- Excellent Communication Skills
- Team Leadership
Certification
- American Society for Quality Certified Quality Auditor
- Duke University School of Medicine ORAQ Regulatory Affairs Training Program
- RQMIS Primary and Secondary Regulatory Requirements for Complaint and Post-Market Surveillance.
Affiliations
American Society for Quality (ASQ)
Timeline
Customer Feedback Manager
ARGON Medical Devices
04.2022 - Current
Regulatory Affairs Lead I
CTL Medical Corp.
06.2018 - 04.2022
Research Technician Crystalline Polymers
Solvay Specialty Polymers
04.2014 - 12.2016
Quality Coordinator Government Affairs
General Dynamics
10.2012 - 04.2014
Quality Control Technician
BWay Corporation
02.2009 - 07.2012
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