Luis Raul Solis Flores
Biomedical Engineer
Ciudad Juarez,Chihuahua
Summary
Effective quality professional bringing proven success in driving continuous improvement initiatives in Quality Engineering roles. Focused and diligent with commitment to fostering corporate mission. Consistently acknowledged for implementing actionable initiative to reduce error rates and optimize company processes.
Overview
10
10
years of professional experience
1
1
Certification
1
1
Language
Work History
Sr. NPI Quality Engineer
Johnson and Johnson
12.2021 - Current
- Provided strategic quality engineering leadership in the development of new products and processes, ensuring adherence to quality systems, regulatory requirements, and design control standards. Oversaw verification and validation activities in accordance with applicable standards and European Essential Requirements under the Medical Device Regulation (MDR). Facilitated efficient product transfers to manufacturing by leading the timely resolution of non-conformances and CAPAs, and conducting comprehensive risk assessments during design reviews. Improved control methods and optimized product acceptance plans by applying Quality Engineering principles to enhance development, transfer, and lifecycle management processes.
NPI Quality Engineer Specialist
Celestica
02.2020 - 10.2021
- Served as the Quality representative on the New Product Introduction (NPI) team, providing expertise and guidance on key aspects such as Functional Specifications, Process Verification, Validation, Test Method Validation, Risk Assessments, and Design Reviews. Supported decision-making to ensure compliance with internal procedures, ISO standards, and FDA regulations throughout all NPI phases. Managed essential deliverables, including the establishment of quality requirements, and coordination of qualification testing. Contributed to the continuous improvement of quality systems by enhancing process control, risk management, and testing methodologies. Mentored cross-functional teams, driving the identification, prioritization, and resolution of quality issues using systematic problem-solving methodologies.
NPI Quality Engineer
GE Healthcare
02.2018 - 02.2020
- Developed and maintained comprehensive quality plans and risk management files to support new product designs, ensuring product safety, efficacy, and regulatory compliance. Provided oversight for design control deliverables within New Product Introduction (NPI) and transfer projects, ensuring timely execution and accurate status reporting. Led cross-functional teams to maintain product quality and regulatory adherence while driving continuous improvement through Six Sigma and LEAN manufacturing methodologies. Designed and executed robust verification and validation strategies to optimize process performance and compliance. Directed corrective and preventive actions (CAPA), addressing product and process issues with a risk-based approach. Supported external regulatory audits and conducted internal audits to ensure conformance with Quality Management System (QMS) standards.
Quality Assurance Engineer
BARD
06.2015 - 02.2018
- Conducted validation studies for new products, processes, and equipment, providing technical support to address quality issues during development, pilot, and manufacturing phases. Led quality engineering studies to identify root causes of non-conformances, ensuring equipment and process compliance through validation activities. Developed and documented QC inspection instructions while reviewing and refining manufacturing procedures to ensure quality and regulatory compliance. Drove continuous improvement initiatives using Lean methodologies and enhanced operational performance through process redesigns and equipment upgrades. Ensured compliance with FDA and GMP regulations through required qualification studies and maintained high-quality standards across all stages of production.
Education
Bachelor of Science - Biomedical Engineering
Universidad Autonoma De Ciudad Juarez
Ciudad Juarez, ChihuahuaSkills
Process Validation
Problem Solving Techniques
Quality Management System
Team Leadership
Risk Management
ISO 13485 Knowledge
Root Cause Analysis
Additional Information
- Root Cause Analysis (Problem Solving) and PFMEA
- CAPA Leader
- Lean Six Sigma Green Belt
- 14 steps for lean development process by SMC group
Certification
Certified Quality Engineer, American Society for Quality (ASQ)
Timeline
Certified Quality Engineer, American Society for Quality (ASQ)
10-2024
Sr. NPI Quality Engineer
Johnson and Johnson
12.2021 - Current
NPI Quality Engineer Specialist
Celestica
02.2020 - 10.2021
NPI Quality Engineer
GE Healthcare
02.2018 - 02.2020
Quality Assurance Engineer
BARD
06.2015 - 02.2018
Bachelor of Science - Biomedical Engineering
Universidad Autonoma De Ciudad Juarez
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