Medical Device Process Validation Engineer (IQ/OQ/PQ)

Flextronics - The Flex Company; Tequesquitlán; On-site; MXN 350,000 - 550,000; Full time

Benefits offered by this job

Pantry vouchers

Saving Fund

Christmas bonus

Holiday bonus

Medical Insurance

Life Insurance

Job summary

Flex is seeking a Process Validation Engineer (Medical Devices) to join our Juarez South operations. You will lead validation activities for manufacturing processes, equipment, and systems, and ensure compliance with FDA and ISO 13485 standards.

You will develop and execute validation protocols, support NPI, perform risk assessments, and collaborate with Quality, Manufacturing, Regulatory Affairs, and R&D to drive quality improvements and on-time deliverables.

Qualifications

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

Responsibilities

• Lead validation activities for manufacturing processes, equipment, and systems (IQ/OQ/PQ/TMV).
• Develop, execute, and approve validation protocols and reports to FDA/ISO 13485 and internal quality requirements.
• Support NPI activities, ensuring validation deliverables are completed on time.
• Evaluate process changes and determine validation impact, revalidation requirements.
• Perform statistical analysis and capability studies to support validation and continuous improvement.
• Collaborate with Quality, Manufacturing, Regulatory Affairs, and R&D.
• Conduct PFMEA-based risk assessments.
• Investigate process deviations, nonconformances, and CAPA activities.
• Support internal, customer, and regulatory audits with validation documentation.
• Develop and maintain validation master plans, protocols, reports, and docs.
• Identify and implement process improvements to enhance quality, compliance, productivity, and cost efficiency.

Skills

IQ/OQ/PQ/TMV validation

Statistics

PFMEA

CAPA investigations

Root cause

Cross-functional leadership

Project management

English proficiency

Education

Bachelor’s degree in Engineering

Job description

Flex is seeking a Process Validation Engineer (Medical Devices) to join our Juarez South operations. You will lead validation activities for manufacturing processes, equipment, and systems, and ensure compliance with FDA and ISO 13485 standards.

You will develop and execute validation protocols, support NPI, perform risk assessments, and collaborate with Quality, Manufacturing, Regulatory Affairs, and R&D to drive quality improvements and on-time deliverables.