Quality Engineer II: Medical Devices & Validation

Fresenius Medical Care; Reynosa; Presencial; MXN 420.000 - 660.000; Jornada completa

Descripción de la vacante

Fresenius Medical Care Reynosa plant is seeking a Quality Engineer II to support quality systems and validation in a regulated manufacturing environment for dialysis disposables and related products.

The role focuses on audits, design control, risk assessment, process validation (IQ/OQ/PQ), data analysis, and continuous improvement, collaborating with cross-functional teams to ensure product quality and regulatory compliance.

Formación

• Bachelor’s degree in mechanical, electrical, electromechanical, biomedical, or related engineering field.
• 2-5 years of experience in Quality Engineering, Medical Device Manufacturing, Pharmaceutical Manufacturing, or related labs.
• Experience with process validation (IQ/OQ/PQ), RCA, risk analysis, DOE, and Gage R&R.
• Proficiency in Minitab, SAP, and Microsoft Office.
• Bilingual English/Spanish; US visa required; willingness to travel domestically and internationally.

Responsabilidades

• Support quality initiatives, compliance objectives, and quality planning activities.
• Participate in audits as a member of the site Audit Team.
• Support design control for new and existing products.
• Conduct risk assessments using FMEA, FMECA, Fault Tree Analysis and Hazard Analysis.
• Lead and support process and test method validations (IQ, OQ, PQ).
• Develop and maintain quality documentation (SOPs, ETRs, drawings, specs, reports).
• Perform root cause analysis, process capability studies, and continuous improvement.
• Conduct and interpret statistical analyses including DOE, correlation and regression, acceptance sampling, and Gage R&R.
• Ensure compliance with regulatory requirements.
• Support cross-functional quality projects and travel for audits/ validations.

Conocimientos

Process validation

Root cause analysis

Risk analysis

DOE (Design of Experiments)

Gage R&R

Analytical problem-solving

Technical writing

Presentation skills

Bilingual English/Spanish

Willingness to travel

Educación

Engineering degree (Mechanical / Electrical / Electromechanical / Biomedical)

Herramientas

Minitab

SAP

Microsoft Office

Descripción del empleo

Fresenius Medical Care Reynosa plant is seeking a Quality Engineer II to support quality systems and validation in a regulated manufacturing environment for dialysis disposables and related products.

The role focuses on audits, design control, risk assessment, process validation (IQ/OQ/PQ), data analysis, and continuous improvement, collaborating with cross-functional teams to ensure product quality and regulatory compliance.