Quality Engineer II

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.