Lucas Villela
@lucasvillela
Quality Integration Lead at Stryker harmonizing site QMS and preparing for regulatory audits.
Costa RicaWhat I'm looking for
At Stryker, I lead site-level integration initiatives, harmonizing the local QMS with corporate and regulatory requirements. I built a formal containment record for a site-wide preventive material hold and drive audit readiness during the integration.
At Medtronic Brazil, I handled customer complaints, investigated product issues, reported adverse events to ANVISA, and compiled post-market data for Clinical Evaluation Reports. Across medical device roles, I've also supported CAPAs, supplier quality, process improvement, and equipment qualification.
Experience
Work history, roles, and key accomplishments
Lead site-level Quality integration initiatives, ensuring alignment with global objectives and regulatory requirements. Drive QMS gap assessments, audit readiness, and risk mitigation during integration.
Manufacturing Engineer III – International Talent Assignment
Feb 2025 - Jul 2025 (5 months)
Supported customer complaint investigations, nonconformances, and CAPAs. Collaborated on site expansion projects for PFA devices, ensuring quality and regulatory alignment.
Led cross-functional projects, CAPAs, and process improvement initiatives. Designed and coordinated engineering tests, analyzing data and reporting results to stakeholders.
Quality Systems Specialist / Supplier Quality Engineer
Aug 2017 - Nov 2021 (4 years 3 months)
Handled customer complaints, investigated product issues, and reported adverse events to ANVISA. Managed CAPA and SCAPA processes and supported supplier quality management.
Led a QA/QC team of 10 inspectors and drove process improvement initiatives focusing on quality, safety, and productivity. Managed workforce planning and people development.
Quality Coordinator
IS Metrology and Technical Services
Nov 2009 - Dec 2014 (5 years 1 month)
Coordinated a team of 3 quality analysts and managed client calibration programs. Supported internal and external audits and implemented improvements in quality systems for ISO 17025.
Education
Degrees, certifications, and relevant coursework
ULATINA
Master's degree, Medical Devices Management
2026 -
Ongoing Master's degree in Medical Devices Management at ULATINA, Costa Rica, expected to continue beyond 2026.
UNIP
Bachelor's degree, Mechanical Engineering
2014 - 2019
Bachelor's degree in Mechanical Engineering from UNIP, Brazil, completed in 2019.
SENAC
Postgraduate Specialization, Project Management
2011 - 2013
Postgraduate Specialization in Project Management with PMI practices from SENAC, Brazil, completed in 2013.
University Barao de Maua
Graduation degree, Quality Management and Work Safety
2008 - 2010
Graduation degree in Quality Management and Work Safety from University Barao de Maua, Brazil, completed in 2010.
HSC Global
Lead Auditor ISO 13485:2016, Auditing
Lead Auditor ISO 13485:2016 certification from HSC Global, with Exemplar Global mark, completed in August 2026.
Dimension Consulting
FDA 21 CFR Part 820, Regulatory Affairs
Completed FDA 21 CFR Part 820 training from Dimension Consulting, 16 hours.
FM2S
Green Belt, Lean Six Sigma
Completed Green Belt Lean Six Sigma training from FM2S, 40 hours.
Medtronic
FTQ - First Time Quality, Quality
Completed FTQ - First Time Quality training from Medtronic, 16 hours.
Othimiza Consulting
SCRUM Master, Project Management
Completed SCRUM Master training from Othimiza Consulting, 16 hours.
REMESP
Measurement Uncertainty Calculation, Metrology
Completed Measurement Uncertainty Calculation training from REMESP, 16 hours.
Tech stack
Software and tools used professionally
Availability
Location
Costa RicaAuthorized to work in
Salary expectations
Social media
Job categories
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