Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. To support our extraordinary teams who build great products and contribute to our growth, we're looking to add a Process Validation Engineer (Medical Devices) located in Juarez South.
Reporting to the Process Engineering Manager, the Process Engineer's role involves:Lead validation activities for manufacturing processes, equipment, and systems, including IQ, OQ, PQ, and TMV studies.
Develop, execute, and approve validation protocols and reports in compliance with FDA, ISO *, and internal quality requirements.
Perform statistical analysis and capability studies to support process validation and continuous improvement initiatives.
Collaborate with cross-functional teams including Quality, Manufacturing, Regulatory Affairs, and R&D.;
Identify and implement process improvements that enhance quality, compliance, productivity, and cost efficiency.
Bachelor's degree in engineering (Mechanical, Industrial, Biomedical, Manufacturing, Mechatronics, or related field). Advanced English communication skills.
Minimum 3-5 years of experience in medical devices, pharmaceutical, or regulated manufacturing environments.
Proficiency in statistical tools, process capability studies, and data analysis.
Experience with CAPA, nonconformance investigations, and root cause analysis methodologies.
Strong project management and cross-functional leadership skills.
To be considered for a position at Flex, you must complete the application process first). #

📌 Process Validation Engineer (Juárez)
🏢 Flex
📍 Juárez