Quality Engineer II — Medical Devices & Process Validation

CH01 CHE Fresenius Medical Care (Schweiz) AG; Reynosa; Presencial; MXN 420.000 - 600.000; Jornada completa

Descripción de la vacante

Fresenius Medical Care's Reynosa plant in Mexico is seeking a Quality Engineer II to support quality initiatives and participate in audits, while contributing to design control activities for medical devices. You will conduct risk assessments and drive validation efforts, including IQ/OQ/PQ, and maintain technical documentation.

The role requires 2–5 years in Quality Engineering, strong analytical skills, proficiency with Minitab/SAP, and bilingual English/Spanish abilities with travel

Formación

• Bachelor’s degree in engineering; advanced degree preferred.
• 2–5 years in Quality Engineering or related manufacturing.
• Experience with IQ/OQ/PQ, RCA, Risk Analysis, DOE, CP, and Gage R&R.

Responsabilidades

• Support quality initiatives, compliance objectives, and quality planning.
• Participate in audits as a site Audit Team member.
• Support design control activities for new and existing products.
• Conduct risk assessments using FMEA and related methods.
• Lead and support process and test method validations (IQ/OQ/PQ).
• Develop and maintain quality documentation (SOPs, ETRs, drawings, specs).
• Perform root cause analysis and continuous improvement activities.
• Carry out statistical analyses including DOE, Gage R&R, and regression.
• Ensure compliance with regulatory requirements and support audits.

Conocimientos

Quality engineering

Process validation IQ/OQ/PQ

Root cause analysis

Risk analysis

DOE

Gage R&R

Engineering drawings

Minitab

SAP

Microsoft Office

Technical writing

Bilingual English/Spanish

Travel readiness

Educación

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

Advanced degree preferred

Herramientas

Minitab

SAP

Microsoft Office

Descripción del empleo

Fresenius Medical Care's Reynosa plant in Mexico is seeking a Quality Engineer II to support quality initiatives and participate in audits, while contributing to design control activities for medical devices. You will conduct risk assessments and drive validation efforts, including IQ/OQ/PQ, and maintain technical documentation.

The role requires 2–5 years in Quality Engineering, strong analytical skills, proficiency with Minitab/SAP, and bilingual English/Spanish abilities with travel