Ericka Guirados
Miami
Summary
Senior Director with 20+ years in Quality and Regulatory Affairs across Medical Devices, Aerospace, and Food industries. Expert in leading global teams, driving strategic planning, process improvement, and technology integration. Recognized for adaptability, collaboration, and delivering reliable, compliant operations while upholding the highest standards of ethics and patient safety
Overview
24
24
years of professional experience
1
1
Certification
Work History
Sr. Quality and Regulatory Affairs Systems Director
Medtronic
01.2011 - Current
- Directed global QA/RA operations for Canada and Latin America, ensuring quality compliance and regulatory strategy across 40 countries and 600+ distributors.
- Developed and executed regional strategies supporting product approvals, market expansion, and portfolio management for 8,000+ licenses, with 3,000 annual submissions.
- Led major reorganizations and contributed to three divestitures, driving transformation and business continuity.
- Built influential advocacy and regulatory relationships, representing Medtronic in key trade associations and regulatory forums, including co-chairing ADVAMED Latin America.
- Championed ethical conduct, inspection readiness, and operational excellence, maintaining a record of zero major findings while modernizing processes and implementing AI solutions.
- Led cross-functional teams in process simplification, automation, and analytics, optimizing distributor management, internal audits, and workforce analysis to drive informed decision-making and operational effectiveness.
- Served as the primary regulatory advisor to cross-functional teams and executive leadership.
Quality Engineer
B/E Aerospace Consumables Management
01.2008 - 01.2011
- Project leader for ISO 9001, AS9120, and AS9100 certification; developed documentation systems and training programs.
- Implemented supplier management and self-release processes, reducing non-value-added inspections.
- Developed corrective action systems, improving complaint response time from 120 to 30 days.
- Enhanced internal audit systems and created audit tools based on ISO and AS standards.
Quality Control Analyst/Supervisor
Bolton Medical, Inc.
01.2005 - 01.2008
- Managed QMS support for manufacturing operations of endovascular and interventional medical devices.
- Coordinated sterilization validation and re-validation processes per ISO standards.
- Developed statistical process control programs and reduced nonconformity rates.
- Led complaint investigations, reducing customer response time from 90 to 30 days.
Planner
Premier Food Service
01.2004 - 01.2005
- Established production plans and managed raw material inventory and purchasing.
- Developed and implemented strategic plans to enhance operational efficiency across food service operations.
- Coordinated cross-functional teams to optimize supply chain management and inventory control processes.
- Led training programs for staff on best practices in food safety and quality assurance standards.
Quality Assurance Analyst & Laboratory Supervisor
Foods Mavesa (Alimentos Mavesa)
01.2002 - 01.2004
- Performed inspections and supervised laboratory testing for food products.
- Updated SOPs for ISO 9001:2000 compliance and successful re-certification.
- Implemented SAP Quality Control Module and SPC for process improvement.
Education
B.S. - Chemical Engineering
University of Carabobo
12.2002
Skills
Global team leadership and collaboration across diverse regions
Change management and organizational development, driving adaptability and continuous improvement
Strategic budget management and workforce planning for operational efficiency
Advanced emotional and business intelligence, fostering trust and positive work culture
Strong problem-solving abilities, navigating uncertainty with flexibility and delivering innovative solutions
Accomplishments
· Successfully led organizations to attain key international quality certifications (AS9001, ISO9001), demonstrating a commitment to global standards and operational excellence.
· Drove regulatory innovation by advocating for and achieving widespread adoption of electronic Instructions for Use (e-IFU) across Latin America, enhancing compliance and accessibility.
· Delivered significant cost savings, over $1 million by strategically optimizing license renewals, focusing on low-demand/low-revenue licenses and achieving substantial reductions over two consecutive years.
Certification
- Quality Auditor (CQA-ASQ)
- Six Sigma Green Belt
Languages
Spanish
Native or Bilingual
English
Native or Bilingual
Portuguese
Professional Working
Timeline
Sr. Quality and Regulatory Affairs Systems Director
Medtronic
01.2011 - Current
Quality Engineer
B/E Aerospace Consumables Management
01.2008 - 01.2011
Quality Control Analyst/Supervisor
Bolton Medical, Inc.
01.2005 - 01.2008
Planner
Premier Food Service
01.2004 - 01.2005
Quality Assurance Analyst & Laboratory Supervisor
Foods Mavesa (Alimentos Mavesa)
01.2002 - 01.2004
B.S. - Chemical Engineering
University of Carabobo
Professional Development
- Leadership development training (Elevate, LEAD), Medtronic, Inc.,
- Change Acceleration Process (CAP), Medtronic, Inc.,
- Quality Auditor Certification (CQA-ASQ),
- Manufacturing Process Control (MPC), Honeywell Aerospace,
- AS9100/9120 Auditor Training & RCCA, B/E Aerospace,
- Internal Auditing Training, SFMA/ASQ,
- Six Sigma Green Belt, Villanova University,
- SOPs for FDA Part 11 Compliance,
- Supplier Controls & Audits,
- Internal Auditing Training for ISO 13485, STAT-A-MATRIX/ASQ,
- ISO 9001:2000 Quality Management Systems,