Quality Systems Engineer I — Medical Device Quality & CAPA

Fresenius Medical Care; Reynosa; Presencial; MXN 180.000 - 240.000; Jornada completa

Descripción de la vacante

Fresenius Medical Care seeks a Quality Systems Engineer I to support site quality initiatives, investigations, validations, and continuous improvement, under supervision. You will ensure compliance with FDA, cGMP, and Quality System Regulations while supporting manufacturing operations and product quality.

Requirements include a Bachelor’s in engineering/science, 0–2 years’ experience, and bilingual English/Spanish. Travel may be required. Proficiency with Microsoft Office is expected.

Formación

• 0–2 years of experience in Quality Engineering, Quality Systems, or Process Validation; medical device/pharma/lab exposure preferred.
• Bilingual English/Spanish.
• Knowledge of FDA regulations (QSR, cGMP, GLP), process validation, risk management, and SPC.
• Experience with CAPA, nonconformance management, and investigations.

Responsabilidades

• Support development and maintenance of Quality Plan and Quality System procedures.
• Participate in Risk Management Files and information exchange across facilities.
• Assist in process validations (IQ, OQ, PQ) and ECOs; maintain validation records.
• Investigate product complaints, nonconformances, and CAPAs; prepare reports.

Conocimientos

Quality systems

CAPA

Risk management

Statistical process control

Investigations

English/Spanish bilingual

Microsoft Office

Educación

Bachelor's degree in Engineering, Science, Chemistry, Biology

Herramientas

Microsoft Office

Descripción del empleo

Fresenius Medical Care seeks a Quality Systems Engineer I to support site quality initiatives, investigations, validations, and continuous improvement, under supervision. You will ensure compliance with FDA, cGMP, and Quality System Regulations while supporting manufacturing operations and product quality.

Requirements include a Bachelor’s in engineering/science, 0–2 years’ experience, and bilingual English/Spanish. Travel may be required. Proficiency with Microsoft Office is expected.