Process Validation Engineer - Medical Devices (IQ/OQ/PQ)

Flex; Ciudad Juárez; On-site; MXN 700,000 - 1,000,000; Full time

Benefits offered by this job

Pantry vouchers

Saving Fund

Christmas bonus

Holiday bonus

Medical Insurance

Life Insurance

EM57

Job summary

Flex is seeking a Process Validation Engineer (Medical Devices) to join our Juarez South team. You will lead IQ/OQ/PQ/TMV validation activities for processes, equipment and systems, ensuring compliance with FDA and ISO 13485 requirements.

You will collaborate with Quality, Manufacturing, Regulatory Affairs and R&D to support NPI, perform risk assessments, and drive CAPA investigations while developing validation master plans and reports.

Qualifications

• Bachelor's degree in engineering (Mechanical/Industrial/Biomedical/Manufacturing/Mechatronics or related).
• Advanced English communication skills.
• 3–5 years of experience in medical devices or regulated manufacturing.
• Experience with IQ, OQ, PQ and processing validation activities.
• Proficiency in statistical tools and data analysis.
• Knowledge of PFMEA and risk management.
• Experience with CAPA and root cause analysis.
• Strong cross-functional leadership and project management.

Responsibilities

• Lead validation activities for processes, equipment, and systems (IQ, OQ, PQ, TMV).
• Develop, execute, and approve validation protocols and reports per FDA/ISO 13485.
• Support NPI with timely validation deliverables.
• Perform risk assessments using PFMEA and other tools.
• Conduct statistical analysis and capability studies for validation.
• Collaborate with Quality, Manufacturing, Regulatory Affairs, and R&D.
• Investigate deviations, nonconformances, CAPA activities.
• Prepare validation master plans, protocols, and reports.
• Assist audits with validation documentation and expertise.
• Identify process improvements for quality, productivity, and cost.

Skills

Advanced English

Cross-functional leadership

Project management

Education

Engineering degree

Tools

Statistical analysis tools

PFMEA

Job description

Flex is seeking a Process Validation Engineer (Medical Devices) to join our Juarez South team. You will lead IQ/OQ/PQ/TMV validation activities for processes, equipment and systems, ensuring compliance with FDA and ISO 13485 requirements.

You will collaborate with Quality, Manufacturing, Regulatory Affairs and R&D to support NPI, perform risk assessments, and drive CAPA investigations while developing validation master plans and reports.