Quality Engineer – Medical Device Manufacturing

Fresenius Medical Care; Reynosa; On-site; MXN 480,000 - 720,000; Full time

Job summary

Fresenius Medical Care in Reynosa is seeking an Advanced Manufacturing Quality Engineer for Active Medical Devices. You will provide technical Quality Engineering support to manufacturing processes and collaborate with cross-functional teams to ensure compliance and product quality.

The role requires a Bachelor’s degree in engineering, 3+ years in quality/manufacturing engineering in regulated environments, experience with CAPA, nonconformance, process validation, and statistical analysis.

Qualifications

• Bachelor’s degree in engineering; 3+ years in quality/manufacturing engineering in regulated environments.
• Experience in active medical device manufacturing or electronics is preferred.
• Strong root cause analysis and nonconformance management capabilities.
• Knowledge of CAPA processes, PFMEA, and quality investigations.
• Familiarity with ISO 13485 and FDA QSR requirements.
• Proficient with statistical tools and basic process validation concepts.

Responsibilities

• Provide technical Quality Engineering support to manufacturing processes for active medical devices.
• Analyze quality data and process trends to identify issues and improvement opportunities.
• Lead technical walkthroughs to identify quality risks and optimization steps.
• Support cross‑functional teams during investigations and CAPA implementation.
• Lead root cause investigations for nonconformances and deviations.
• Assist in design transfer, design reviews, and engineering change evaluations.
• Review manufacturing procedures, test methods, and related documentation.
• Support process validation, measurement systems analysis, and quality improvements.

Skills

Quality engineering

Root cause analysis

CAPA investigations

Cross-functional problem-solving

Statistical analysis

Process validation

Manufacturing risk management

ISO 13485 knowledge

FDA QSR knowledge

Minitab

Education

Bachelor’s degree in Electronic, Mechanical, Industrial Engineering or related field

Master’s degree in Engineering or Quality Systems

Tools

Minitab

ERP/MES systems

Quality Management Systems

Job description

Fresenius Medical Care in Reynosa is seeking an Advanced Manufacturing Quality Engineer for Active Medical Devices. You will provide technical Quality Engineering support to manufacturing processes and collaborate with cross-functional teams to ensure compliance and product quality.

The role requires a Bachelor’s degree in engineering, 3+ years in quality/manufacturing engineering in regulated environments, experience with CAPA, nonconformance, process validation, and statistical analysis.