Senior Quality Engineer, Non-Active Medical Devices

Fresenius Medical Care; Reynosa; Hybrid; MXN 350,000 - 520,000; Full time

Benefits offered by this job

Career development opportunities

Innovative culture

Global employer with mid-sized feel

Job summary

Fresenius Medical Care is seeking a Senior Quality Engineer for Non-Active Medical Devices in Reynosa, Mexico. The role focuses on ensuring product and process quality across manufacturing, with a SME focus on CAPA, root cause analysis, and design transfer.

You will collaborate with Manufacturing, Product Engineering, and Supplier Quality to uphold ISO 13485, FDA 21 CFR Part 820, and MDSAP compliance. The ideal candidate has 3–5 years of quality/ manufacturing engineering experience in regulated

Qualifications

• Bachelor’s degree in a relevant engineering field and 3–5 years in quality/manufacturing engineering in regulated medical devices.
• Experience leading complex quality investigations and CAPA systems.
• Experience with design transfer, PFMEA, SP C, and risk management.
• Knowledge of ISO 13485, FDA 21 CFR Part 820, and MDSAP is preferred.

Responsibilities

• Serve as SME for quality engineering on Non-Active Medical Devices (NAMD).
• Analyze quality trends, process capabilities, and defect patterns to identify systemic issues.
• Lead root cause investigations and CAPA effectiveness assessments.
• Provide technical leadership during design transfer and engineering changes.
• Support process validation, TMV, equipment qualification, and MSA activities.

Skills

CAPA investigations

Root cause analysis

Statistical analysis

Process validation

Lean Six Sigma

Leadership

Education

Bachelor’s Degree in Electronic, Mechanical, Industrial Engineering

Tools

Minitab

MS Excel

ERP/MES

Job description

Fresenius Medical Care is seeking a Senior Quality Engineer for Non-Active Medical Devices in Reynosa, Mexico. The role focuses on ensuring product and process quality across manufacturing, with a SME focus on CAPA, root cause analysis, and design transfer.

You will collaborate with Manufacturing, Product Engineering, and Supplier Quality to uphold ISO 13485, FDA 21 CFR Part 820, and MDSAP compliance. The ideal candidate has 3–5 years of quality/ manufacturing engineering experience in regulated