Medical Device Process Validation Engineer – IQ/OQ/PQ Lead

Flex; Juarez; On-site; MXN 600,000 - 900,000; 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 support validation activities in Juarez South. You will lead IQ/OQ/PQ and TMV studies, develop validation protocols, and ensure compliance with FDA and ISO 13485 standards.

The role collaborates with Quality, Manufacturing, Regulatory Affairs, and R&D to drive product quality and regulatory readiness. We value a Bachelor’s degree in engineering and 3–5 years in regulated environments, with strong English skills and a focus on

Qualifications

• Bachelor's degree in engineering or related field.
• Advanced English communication skills.
• 3–5 years in medical devices, pharma, or regulated manufacturing.
• Experience with IQ/OQ/PQ and validation activities.
• Proficiency in statistical tools and data analysis.

Responsibilities

• Lead validation activities for manufacturing processes, equipment, and systems (IQ/OQ/PQ/TMV).
• Develop, execute, and approve validation protocols and reports per FDA/ISO 13485.
• Support NPI validation deliverables and ensure timeliness.
• Perform risk assessments and CAPA-related activities.
• Collaborate with Quality, Manufacturing, Regulatory Affairs, and R&D.

Skills

Advanced English

Project management

Statistical analysis

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

Statistical tools

Job description

Flex is seeking a Process Validation Engineer (Medical Devices) to support validation activities in Juarez South. You will lead IQ/OQ/PQ and TMV studies, develop validation protocols, and ensure compliance with FDA and ISO 13485 standards.

The role collaborates with Quality, Manufacturing, Regulatory Affairs, and R&D to drive product quality and regulatory readiness. We value a Bachelor’s degree in engineering and 3–5 years in regulated environments, with strong English skills and a focus on