Summary
Overview
Work History
Education
Skills
Websites
Certification
Languages
Languages
Timeline
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LILIANA BAYLON

Summary

Dedicated Quality Engineer with 4 years of expertise in the Medical Device Industry, specializing in Transfer Validation Projects and adeptly implementing robust quality control systems to uphold compliance with ISO 13485:2016 and 21 CFR Part 820 regulations. Experienced in personnel management and skilled at fostering effective collaboration within cross-functional teams to efficiently identify and address quality issues.

Overview

4
4
years of professional experience
1
1
Certification

Work History

Quality Engineer 1

Teleflex
06.2022 - Current
  • Created and executed quality Process Validation Technical documents such as Test Method Validations, Installation Qualifications, and Engineering Test Reports in compliance with industry standards (FDA, ISO 13485, 21 CFR Part 820).
  • Reviewed and approved validation transfer protocols and reports, ensuring adherence to specifications and regulatory requirements.
  • Coordinated and conducted gemba walks to identify corrective actions in production processes, ensuring alignment with GMP and ISO standards.
  • Involved in continuous improvement initiatives using A3 methodology to enhance process efficiency and ensure compliance.
  • Conducted Test Method Validation on attribute an variable data ensuring accuracy and product quality.
  • Ensured adherence to Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs) in accordance with established procedures, aligning with 21 CFR Part 820 and ISO 13485:2016 standards to uphold the quality standards of our products.
  • Directed quality transfer activities, including the revision and enhancement of Quality Inspection Procedures and Manufacturing resulting in improved process controls and defect reduction.
  • Managed non-conformance (NC) issues related to manufacturing processes, materials, and packaging workflows, implementing corrective and preventive actions.
  • Led internal audits and participated in external audits (KGMP) to ensure regulatory compliance and continuous improvement.
  • Provided quality engineering support for 4 months at a sister plant, ensuring process adherence and quality standards.
  • Participated as part of the backroom team during an external audit at the sister plant, assisting in audit preparation and ensuring the resolution of any non-compliances.
  • Assisted in the onboarding and training of new hires on quality standards, regulations, and procedures.
  • Supervised quality inspectors throughout validation procedures, guaranteeing adherence to established protocols and procedures
  • Coordinated and mentored engineering interns, leading the planning and execution of tasks, providing technical guidance, and ensuring their professional growth. Helped interns develop skills and knowledge, resulting in their successful transition to engineering roles.
  • Implemented Semi-automated routines on OGP Vision System to improve inspection times of molded parts by up to 40%.

Quality Technician

Teleflex
11.2021 - 06.2022
  • Creation and follow-up of Nonconformance Notifications
  • Coordinated 'Be Ready Audits' and Gemba walks
  • Data Analysis of quality metrics such as scrap and DPM
  • Monitoring field-level performance and reporting on the current status and potential improvements through research and root cause analysis
  • Cross functional teamwork in the creation of A3's tool for problem solving
  • Data Analysis of performance indicators by using SPC software to monitor, analyze and optimize production processes.

Engineering Technician

Teleflex
05.2021 - 10.2021
  • Document control of procedures and device history records
  • Monitored scrap rate
  • Responsible of Equipment records
  • Cross training on manufacturing process for a transferred product
  • Monitored the correct performance according to the Manufacturing Procedures.

Maintenance Assistant/Intern

Teleflex
02.2021 - 05.2021
  • Responsible of controlling preventive and corrective maintenance records of Manufacturing site
  • Activities and itinerary planning for Intendant personnel
  • Direct dealings with suppliers
  • Realization and follow-up of Purchase requisitions.

Education

Medical Manufacturing Engineering Diploma -

Cetys Universidad

Bioengineer -

Universidad Autonoma De Baja California

Skills

  • Problem-solving abilities
  • Adaptability
  • Leadership
  • Communication
  • Work ethic
  • Team work
  • Organization Skills
  • Bilingual
  • Data analysis
  • Basic knowledge on MS office: -Excel,: use of pivot table, formula functions, formatting 1-Word:,Formatting and Page set-up, editing 2-Outlook,: Navigation 3-PowerPoint: Presentation design 4SAP System( NC's Inspection procedure)
  • Basic knowledge in the use of measuring tools (Vision System, Caliper, Laser Micrometer)

Certification

  • Minitab Masters with Statistical Process Control (SPC) Certificate by Cusum Academy.
  • Quality Engineer Refresh Course Certificate by ASQ.
  • Internal Auditor ISO 13485:2016 and GMP 21 CFR Part 820 Certificate by SAC Capacitación Integral.
  • Lead Auditor ISO 19011:2018
  • TWI Job Instruction

Languages

  • English, Professional
  • Spanish, Native/ Bilingual

Languages

English
Full Professional
Spanish
Native/ Bilingual

Timeline

Quality Engineer 1

Teleflex
06.2022 - Current

Quality Technician

Teleflex
11.2021 - 06.2022

Engineering Technician

Teleflex
05.2021 - 10.2021

Maintenance Assistant/Intern

Teleflex
02.2021 - 05.2021

Medical Manufacturing Engineering Diploma -

Cetys Universidad

Bioengineer -

Universidad Autonoma De Baja California

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LILIANA BAYLON