Quality Engineer II
Fresenius Medical Care · Bogotá
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.
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