Quality Engineer II – Medical Devices, Validation & Compliance

Freseniusmedicalcare; Reynosa; Presencial; MXN 420.000 - 630.000; Jornada completa

Descripción de la vacante

Fresenius Medical Care in Reynosa, Mexico seeks a Quality Engineer II to strengthen quality systems in a regulated manufacturing environment for dialysis products. You will contribute to compliance and continuous improvement across the site.

Responsibilities include risk assessments, validation activities, and updating technical documentation. Strong English/Spanish skills, travel readiness, and a working visa are preferred to support global audits and cross-functional projects.

Formación

• Bachelor’s degree in mechanical, electrical, electromechanical, biomedical, or related Engineering field. Advanced degree preferred.
• 2-5 years of experience in Quality Engineering, Medical Device Manufacturing, Pharmaceutical Manufacturing, and/or Laboratory environments.
• Strong technical, analytical, and problem-solving skills.
• Experience with Process Validation (IQ/OQ/PQ), Root Cause Analysis, Risk Analysis, DOE, Process Capability Studies, and Gage R&R.
• Knowledge of manufacturing processes, SOPs, engineering drawings, equipment specifications, and testing methods.
• Proficiency in Minitab, SAP, and Microsoft Office.
• Strong technical writing and presentation skills.
• Bilingual (English/Spanish).
• U.S. Visa required.
• Availability to travel domestically and internationally.
• German language proficiency is preferred but not required.

Responsabilidades

• Support quality initiatives, compliance objectives, and quality planning activities.
• Participate in internal and external audits as a member of the site Audit Team.
• Support design control activities for new and existing products.
• Conduct risk assessments using FMEA, FMECA, Fault Tree Analysis, Hazard Analysis, and equivalent methodologies.
• Lead and support process and test method validations, including IQ, OQ, and PQ activities.
• Develop and maintain quality documentation, including procedures, SOPs, ETRs, drawings, equipment specifications, and technical reports.
• Perform root cause analysis, process capability studies, and continuous improvement activities.
• Conduct and interpret statistical analyses including DOE, Correlation & Regression, Acceptance Sampling, and Gage R&R studies.
• Ensure compliance with corporate, state, federal, and regulatory requirements.
• Support cross-functional quality projects and travel as required for audits, validations, training, and process-related activities.

Conocimientos

Quality engineering

Root cause analysis

DOE

Process validation

Risk analysis

Statistical analysis

Educación

Bachelor's degree in mechanical, electrical, electromechanical, biomedical engineering

Herramientas

Minitab

SAP

Microsoft Office

Descripción del empleo

Fresenius Medical Care in Reynosa, Mexico seeks a Quality Engineer II to strengthen quality systems in a regulated manufacturing environment for dialysis products. You will contribute to compliance and continuous improvement across the site.

Responsibilities include risk assessments, validation activities, and updating technical documentation. Strong English/Spanish skills, travel readiness, and a working visa are preferred to support global audits and cross-functional projects.