Quality Engineer II

About the role

Fresenius Medical Care seeks a Quality Engineer II to support quality planning, internal audits, data analysis, and design qualification for medical devices at its Bogotá plant. The role works with cross‑functional teams to ensure products meet regulatory and design control requirements.

Key responsibilities

• Perform routine quality tasks using established procedures and maintain accurate quality records.
• Conduct problem identification, root‑cause analysis, and corrective actions for internal operations and suppliers.
• Represent the Quality Department on supplier improvement and process improvement teams.
• Apply statistical methods such as sampling distributions, correlation, regression, DOE, and acceptance sampling.
• Conduct Gage R&R studies and use statistical software and quality tools (risk analysis, control charts, histograms, etc.).
• Integrate risk management throughout the product lifecycle and maintain workplace housekeeping.

Required profile

• Professional studies in Pharmaceutical Chemistry, Chemistry, Chemical Engineering, Biomedical Engineering, Materials Engineering, Industrial/Production/Process Engineering, or Microbiology.
• At least 2 years of quality‑related experience.
• Ability to read, analyze, and interpret scientific and technical publications.
• Intermediate to upper‑intermediate conversational English.
• Strong analytical and problem‑solving skills for manufacturing and product design issues.

Required skills

• Statistical analysis and use of statistical software.
• Design of Experiments (DOE) and acceptance sampling.
• Gage Repeatability & Reproducibility (Gage R&R) studies.
• Risk management techniques.
• Quality auditing and documentation.

What we offer

• Professional growth opportunities and individual career planning.
• Corporate culture that encourages innovative thinking.
• Diverse community of dedicated professionals.
• Benefits of a global organization combined with a collaborative mid‑size company environment.