Juana Jesus Martinez Lizarraga
Tijuana,Baja California
Summary
Biochemical Engineer with 8 years of experience in the medical industry, specializing in controlled environments and sterilization processes. Expertise extends to new product introduction, quality assurance in manufacturing processes, and supplier management. Results-driven professional excelling at enhancing team collaboration and delivering consistent, high-quality outcomes. Adaptable to evolving demands with strong skills in strategic decision-making and conflict management.
Overview
9
9
years of professional experience
Work History
Sterilization Leader
Corza Medical
06.2024 - Current
- Identified team weak points and implemented corrective actions to resolve concerns.
- Oversaw the daily activities of three engineers in the environmental and sterilization areas, fostering a motivating and inspiring atmosphere.
- Led cross-functional teams to achieve company-wide goals, fostering a culture of collaboration and innovation.
- Managed cleanroom environmental monitoring, bioburden control, and quality audits (DQA) in compliance with ISO 13485, MDD, FDA/QSR, and corporate standards.
- Evaluated root causes of environmental and sterilization issues and implemented corrective actions.
- Assessed and improved cleaning programs in manufacturing areas.
- Developed and maintained quality management systems and documentation.
- Supported customer requests and regulatory audits as the Subject Matter Expert (SME) for Environmental and Sterilization areas.
- Led the implementation of a new Ethylene Oxide sterilizer (second source), resulting in annual savings of over $1 million.
- Managed subcontracted laboratory and sterilization service providers to ensure compliance with quality and regulatory standards.
ENVIRONMENTAL AND STERILIZATION QUALITY ENGINEER
CENTERPIECE S. DE R.L. DE C.V.
08.2019 - 06.2024
- Sanitary responsible, management, activities, and procedures with COFEPRIS
- Design and development of clean rooms, adjacent areas and controlled environments based on the requirements and specifications of each product
- Development, implementation and execution of cleanrooms validations and controlled environments (DQ, IQ, OQ and PQ)
- Develop, implement, and coordinate validation / environmental sampling and sterilization plans for the introduction of medical devices in compliance with regulations
- Development and implementation of procedures for environmental control, formats, diagrams, and layouts
- Monitoring and audits of sterilization and environmental service suppliers
- Selection and Management of suppliers (Management, evaluation, quality agreements and purchase orders)
- Generate, coordinate, and follow up any CAPA, NCMR or Complaint related to Sterilization and Environmental activities
- Development, execution, and support in validation of test methods for medical devices
- Development, implementation, and execution of incoming inspection plans
- Development, implementation, and support in activities related to product/process quality
ENVIRONMENTAL AND STERILIZATION QUALITY ENGINEER
PROVIDIEN DEVICE ASSEMBLY LLC
08.2017 - 06.2019
- Develop and Coordinate Environmental and Sterilization Plans to medical devices implementation
- Develop and Coordinate Environmental and Sterilization Validations
- Develop, implement, and maintain environmental and sterilization sampling plans to be in compliance with international regulation
- Perform Environmental and Sterilization contractor monitoring and audits
- Continuously improve Sterilization and Environmental processes and practices
- Generate, coordinate, and follow up any CAPA, NCMR or Complaint related to Sterilization and Environmental activities
- Customers communication on any item related to Sterilization or Environmental issues
QUALITY ENGINEERING INTERN
PROVIDIEN DEVICE ASSEMBLY LLC
03.2017 - 08.2017
- Support in environmental monitoring in compliance with ISO 14644
- Coordinate and verify the shipping of samples for laboratory tests
- Creation and follow-up of Engineering Change Order (ECO)
- Support activities for engineering and manufacturing processes
- Performing of Engineering Studies and TMV (Validation of Test Methods)
- Follow up of CAPA activities and customer complaints
- Training for operational personnel
MANUFACTURING ENGINEERING INTERN
SENSATA TECHNOLOGIES DE MÉXICO S.A. DE C.V.
09.2016 - 03.2017
- Times and movements studies / Line balancing
- Identification and evaluation of new alternatives for process improvements
- Creation of visual aids and work instructions
- Production of films for the stamping of finished products (Design in AutoCAD)
- Participation in Kaizen for continuous improvement
RESEARCH ASSISTANT
CENTRO DE INVESTIGACIÓN Y DE ESTUDIOS AVANZADOS DEL IPN (CINVESTAV- IRAPUATO, GUANAJUATO)
06.2016 - 08.2016
- Conservation of strains and microbiological samples
- DNA extractions
- PCR analysis + gel electrophoresis
- Virulence tests
- Western blog for proteins
- Acetylene reduction tests
- Optical density measurements / Growth kinetics
- Fuzz Reactions
Education
BIOCHEMICAL ENGINEER - Biotechnology
INSTITUTO TECNOLOGICO DE MÉXICO
01.2017
TECHNICAL ACCOUNTING -
CENTRO DE BACHILLERATO TECNOLÓGICO INDUSTRIAL Y DE SERVICIO NO. 116
01.2012
Skills
- Accountable Professional
- Self-Starter
- Detail-Oriented Organization
- Cross-Disciplinary Expertise
- Passion for Ongoing Education
- Client Support
- Laboratory Instrument Proficiency
- Proficient in Microsoft Office
- Minitab Proficiency
- Proficient in AutoCAD
- Proficient in Visio Diagramming
- Understanding of Cleanroom Standards
- Managed Controlled Areas
- Cleanrooms Management Training
- Hazardous Material Handling
- Sterilization Process Validation
Pc Programs
- Microsoft Office (Excel, Word, PPT)
- Minitab
- AutoCAD
- Mathcad
- Nomipaq, Compaq
- Visio
Languages
English
Professional Working
Spanish
Native or Bilingual
Timeline
Sterilization Leader
Corza Medical
06.2024 - Current
ENVIRONMENTAL AND STERILIZATION QUALITY ENGINEER
CENTERPIECE S. DE R.L. DE C.V.
08.2019 - 06.2024
ENVIRONMENTAL AND STERILIZATION QUALITY ENGINEER
PROVIDIEN DEVICE ASSEMBLY LLC
08.2017 - 06.2019
QUALITY ENGINEERING INTERN
PROVIDIEN DEVICE ASSEMBLY LLC
03.2017 - 08.2017
MANUFACTURING ENGINEERING INTERN
SENSATA TECHNOLOGIES DE MÉXICO S.A. DE C.V.
09.2016 - 03.2017
RESEARCH ASSISTANT
CENTRO DE INVESTIGACIÓN Y DE ESTUDIOS AVANZADOS DEL IPN (CINVESTAV- IRAPUATO, GUANAJUATO)
06.2016 - 08.2016
TECHNICAL ACCOUNTING -
CENTRO DE BACHILLERATO TECNOLÓGICO INDUSTRIAL Y DE SERVICIO NO. 116
BIOCHEMICAL ENGINEER - Biotechnology
INSTITUTO TECNOLOGICO DE MÉXICO
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