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

847 Flextronics Manufacturing Juarez S De Rl De Cv; Ciudad Juárez; On-site; MXN 380,000 - 660,000; Full time

Benefits offered by this job

Pantry vouchers

Saving Fund

Christmas bonus

Holiday bonus

Medical Insurance

Life Insurance

Job summary

847 Flextronics Manufacturing Juarez S De Rl De Cv is seeking a Process Validation Engineer (Medical Devices) in Juarez South. You will lead validation activities, develop protocols, and support FDA/ISO 13485 compliance while coordinating with Quality, Manufacturing, Regulatory Affairs, and R&D.

The role requires a mechanical/industrial/biomedical engineering background, 3–5 years in regulated environments, and advanced English communication.

Qualifications

• 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.
• Strong experience executing and managing IQ, OQ, PQ, and processing validation activities.
• Proficiency in statistical tools, process capability studies, and data analysis.
• Knowledge of risk management methodologies, including PFMEA.
• Experience with CAPA, nonconformance investigations, and root cause analysis methodologies.
• Strong project management and cross-functional leadership skills.

Responsibilities

• 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 13485, and internal quality requirements.
• Support New Product Introduction (NPI) activities, ensuring validation deliverables are completed on time.
• Evaluate process changes and determine validation impact assessments and revalidation 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.
• Conduct risk assessments using PFMEA and other risk management tools.
• Investigate process deviations, nonconformances, customer complaints, and CAPA activities.
• Support internal, customer, and regulatory audits by providing validation documentation and technical expertise.
• Develop and maintain validation master plans, protocols, reports, and associated documentation.
• Identify and implement process improvements that enhance quality, compliance, productivity, and cost efficiency.

Skills

IQ/OQ/PQ validation

Statistical analysis

PFMEA risk management

CAPA investigations

Cross-functional leadership

Advanced English

Education

Bachelor's degree in engineering

Tools

Statistical software

Quality systems training

Job description

847 Flextronics Manufacturing Juarez S De Rl De Cv is seeking a Process Validation Engineer (Medical Devices) in Juarez South. You will lead validation activities, develop protocols, and support FDA/ISO 13485 compliance while coordinating with Quality, Manufacturing, Regulatory Affairs, and R&D.

The role requires a mechanical/industrial/biomedical engineering background, 3–5 years in regulated environments, and advanced English communication.