Quality Engineer II – Medical Devices | Data-Driven Quality

Fresenius Medical Care; Bogotá; Presencial; COP 48.000.000 - 90.000.000; Jornada completa

Descripción de la vacante

Fresenius Medical Care Bogotá plant is seeking a Quality Engineer II to lead quality planning, internal audits, data analysis, and design review across medical devices. You will work with cross-functional teams to ensure compliant, high-quality products throughout development and production.

The role requires a degree in a relevant field and at least two years of quality experience, with English proficiency and strong analytical abilities to support risk management and process improvements.

Formación

• Bachelor's level or equivalent in a relevant scientific/engineering field.
• +2 years of related quality experience.
• English proficiency (intermediate to upper-intermediate).
• Ability to read, analyze, write, and interpret scientific publications.
• Analytical and problem-solving skills for manufacturing processes and product design.

Responsabilidades

• Quality planning and internal audits.
• Prepare inspection records, specifications, and reports ensuring data accuracy.
• Lead problem identification analyses and corrective actions with suppliers.
• Represent Quality Department in supplier improvement and process‑improvement efforts.
• Apply design controls, risk management, and DOE techniques across the product lifecycle.
• Maintain housekeeping and plant cleanliness to support compliance.

Conocimientos

Quality planning

Data analysis

Problem solving

Cross-functional collaboration

Statistical methods

Educación

Professional studies in Pharmaceutical Chemistry / Pharmaceutical Sciences / Chemistry / Chemical Engineering / Biomedical Engineering / Materials Engineering / Industrial Engineering / Production Engineering / Process Engineering / Microbiology

Herramientas

Statistical software

Descripción del empleo

Fresenius Medical Care Bogotá plant is seeking a Quality Engineer II to lead quality planning, internal audits, data analysis, and design review across medical devices. You will work with cross-functional teams to ensure compliant, high-quality products throughout development and production.

The role requires a degree in a relevant field and at least two years of quality experience, with English proficiency and strong analytical abilities to support risk management and process improvements.