Maria Luz Valenzuela Espinoza
Herriman
Summary
Dynamic professional with strong organizational and management skills, recognized for honesty, commitment, and efficiency. A proactive approach to problem-solving drives a consistent pursuit of challenges that foster professional growth and enhance team performance. Focused on generating impactful results and implementing positive changes that contribute to overall organizational success. Adept at navigating complex situations while maintaining a collaborative spirit within diverse teams.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Senior Quality Assurance Engineer
Merit Medical Systems Inc
10.2024 - Current
- Collaborate with other departments to facilitate successful project completion.
- Responsible for risk management documentation for assigned product line(s) or processes.
- Review, approve and generate Engineering Change Notifications to update or generate verification, validation, monitoring and inspection methods, procedures and test protocols.
- Participation in MDR submission projects since the Quality assessment and documentation.
- Identify and implement any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system.
- Perform test method and process validation (IQ, OQ, PQ and/or TMV)
- Participate in design and development activities.
Sr. Quality Engineer
Merit Maquiladora Mexico
03.2021 - 10.2024
- Administration of the Quality System for Validation and Verification Processes activities.
- Calibration area administration.
- Enhanced customer satisfaction with thorough root cause analysis and timely resolution of complaints.
- Collaborated with cross-functional teams to optimize manufacturing, and validation processes.
- Trained and mentored junior engineers, providing guidance and direction.
- Perform Quality Risk documentation (QRMT’s)
- Perform Post market surveillance documentation (PMS)
- Generate Engineering Change Notifications for Quality documents.
- Coordinate, monitoring and follow up to accomplishment of Quality Metrics (NCMR’s/CAPA’s/EPWOs/Customer Complaints) to keep under control and improve results.
- Led to Quality team (Quality Engineers, Technicians and QC inspectors).
- Support to production leading solving problems to determine and implement corrective and preventive actions.
- Internal auditor
Quality Engineering Supervisor
Sistemas Medicos Alaris
11.2014 - 02.2021
- Administration of quality human resource (QC inspectors, Assurance technician, Quality Engineers).
- Coordinate improvement projects with Quality Engineers.
- Coordinate and follow up to accomplishment of quality metrics.
- Escalate critical issues and leading the follow up to provide solutions with the multidisciplinary team.
- Led a team of quality engineers, fostering a collaborative environment that boosted productivity and morale.
- Internal auditor.
- Mentored junior engineers, providing guidance and support for their professional growth within the organization.
Sr. Quality Engineer
Smiths Healthcare Manufacturing
05.2012 - 11.2014
- Monitoring, follow up and improvement to Quality Metrics (NCMR, CAPAs, Complaints).
- Customer complaints investigation.
- Support to production lines.
- Root cause investigation and corrective actions implementation.
- Development and follow up to documentation (ECO’s and deviations).
- Validation projects participation.
- Continuous improvement projects participation.
- Internal auditor
Quality Engineer
Flextronics (AVAILMED)
07.2010 - 05.2012
- Monitoring and follow up to Quality Metrics (NCMR, CAPAs).
- Customer complaints investigation.
- Support to production lines.
- Root cause investigation and corrective actions implementation. Development and follow up to documentation (ECO’s and deviations).
- Validation projects participation.
- Continuous improvement projects participation.
- Internal auditor.
- New Product Transfer Project participation.
Quality Engineer
Muramoto Manufacturing de Mexico
04.2007 - 03.2010
- In charge of incoming, In process and Assurance inspection processes.
- Quality System implementation (Quality Procedures, forms, inspection records, visual aids, work instructions procedures development).
- Customer complaints response.
- Support to production lines.
- Personnel management (Quality inspectors).
Manufacturing Engineer
Foxconn Baja California
03.2006 - 12.2006
- Line balance.
- NCMRs investigation and corrective actions implementation.
- Support to production lines.
- Continuous improvement projects participation.
Education
MBA - Master Business Administration
Pacifico Universidad
Tijuana, Mexico11-2013
Bachelor's Degree - Industrial Engineer
Instituto Tecnológico De Culiacán
Sinaloa, Mexico01.2005
Skills
- Self-motivated
- Teamwork and collaboration
- Constant learning
- Flexibility and adaptability
- Quality assurance metrics
- Protocol review
- Quality audits
- Reliability
- Organizational skills
- Risk assessment
- Professionalism
Accomplishments
- Contribute in the professional development of Quality interns and Junior Engineers.
- Implement a QA functional internal organization for the assigned production area (QA inspectors, Technician and Engineers) to accomplish and improvement of Quality metrics.
- Reduction of overdue Calibration NCs from 95 to 0 overdue.
- Reduction of overdue Non-conformance reports from 52 to 0 overdue.
- Reduction of overdue complaint backlog from 134 to 2 overdue.
- BMRAM training to the new hired personnel.
- Supervised team of 100 members (QA inspectors, Technician and Engineers).
- Participation as Backroom Coordinator for external audits.
Certification
- 2020 BSI; Tijuana, Baja California: Leader Auditor ISO13485:2016 (Certification number: 3170905-222891)
- 2012 IDET; Tijuana, Baja California: Applied Industrial Statistics Course
LANGUAGES
Spanish
English
Interests
- Embracing outdoor adventures such as hiking, rappel, rafting, kayaking, paddleboarding
- Acting
- Singing
- Karate
- Basketball
- Travel
Timeline
Senior Quality Assurance Engineer
Merit Medical Systems Inc
10.2024 - Current
Sr. Quality Engineer
Merit Maquiladora Mexico
03.2021 - 10.2024
Quality Engineering Supervisor
Sistemas Medicos Alaris
11.2014 - 02.2021
Sr. Quality Engineer
Smiths Healthcare Manufacturing
05.2012 - 11.2014
Quality Engineer
Flextronics (AVAILMED)
07.2010 - 05.2012
Quality Engineer
Muramoto Manufacturing de Mexico
04.2007 - 03.2010
Manufacturing Engineer
Foxconn Baja California
03.2006 - 12.2006
MBA - Master Business Administration
Pacifico Universidad
Bachelor's Degree - Industrial Engineer
Instituto Tecnológico De Culiacán
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