At Fresenius Medical Care, we are global leaders in renal care, committed to improving the lives of patients with chronic kidney disease. Our mission is to provide innovative, high-quality products, services, and care throughout the entire healthcare journey. Guided by our vision — “Creating a future worth living. For patients. Worldwide. Every day.” — we act with purpose and compassion, supported by a global team of more than 110,000 employees.

At our Bogotá plant in Colombia, we specialize in the production and distribution of a wide range of high-quality products essential for dialysis therapy and patient care. We manufacture HD and PD solutions, disposables, intravenous solutions, and empty Biofine bags. We also distribute a comprehensive dialysis portfolio, including pharmaceuticals, dialyzers, bloodlines, and dialysis machines.

The Bogotá team plays a vital role in Fresenius Medical Care’s commitment to improving patient care worldwide.

Join our passionate team and be part of this global impact!

Our values guide the way we work:

• We care for our patients, each other, and our communities.
• We connect teams and borders to deliver excellence together.
• We commit to doing things right — growing with purpose and leading renal care through integrity and innovation.

Quality Engineer II

Location: Vía Siberia-Funza en Zona Franca Intexzona, On Site

About the Position:

Responsible for quality planning, internal audits, data collection and analysis, specification development and review, as well as design review and qualification. Works with cross-functional teams to develop, commercialize, and maintain high-quality, innovative, and compliant medical devices, ensuring adherence to design controls, leading and supporting product testing and risk management, developing procedures, and serving as a key resource for related standards and requirements.

Key Responsibilities:

• Uses established procedures to perform assigned routine tasks.
• Understands quality records and is able to prepare inspection records, specifications, and other reports. Applies techniques to ensure data accuracy and integrity.
• Performs problem identification analyses and corrective action investigations for internal operations. Supports problem identification and corrective action efforts for suppliers.
• Represents the Quality Department in supplier improvement or collaboration programs.
• Represents the Quality Department on process improvement teams.
• Demonstrates knowledge of sampling distributions, including binomial, Poisson, normal, and exponential distributions, and applies statistical inference techniques to each.
• Performs correlation and regression analyses, Design of Experiments (DOE), and acceptance sampling. Conducts and interprets repeatability and reproducibility (Gage R&R) studies.
• Analyzes data using statistical software and quality tools, such as risk analysis, flowcharts, control charts, scatter plots, and histograms.
• Applies and integrates risk management techniques throughout the product lifecycle.
• Maintains general housekeeping and cleanliness in the work area and plant.

Requirements:

• Professional studies in Pharmaceutical Chemistry / Pharmaceutical Sciences / Chemistry / Chemical Engineering / Biomedical Engineering / Materials Engineering / Industrial Engineering / Production Engineering / Process Engineering / Microbiology
• + 2 years of related experience in quality
• Ability to read, analyze, write, and interpret common scientific and technical publications.
• Ability to respond to routine inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Intermediate to upper-intermediate conversational English proficiency.
• Demonstrated analytical and problem-solving skills to address issues related to manufacturing processes, as well as product design and use.

What We Offer:

There is so much to discover at Fresenius Medical Care, regardless of your area of expertise or level of experience — everything is designed to support your professional growth.

Whether on the front lines or behind the scenes, your contribution helps make ever-better healthcare available to more people around the world.

• Individual career planning opportunities and the ability to take ownership of your professional development.
• A corporate culture that encourages innovative thinking, enabling us to find the best solutions together, not just the fastest ones.
• A diverse community of dedicated people with a wide range of skills, talents, and experiences.
• The benefits of a successful global organization combined with the collaborative culture of a mid-sized company.