Quality Engineer I

At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey.

Guided by our vision—“Creating a future worth living. For patients. Worldwide. Every day.”—we work with purpose and compassion, supported by a global team of over 110,000 employees.

Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth.

Our values guide how we work:

• We Care for our patients, each other, and our communities
• We Connect across teams and borders to deliver excellence together
• We Commit to doing things the right way—growing with purpose and leading kidney care with integrity and innovation

At our Reynosa plant in Mexico, we are committed to the highest standards in the production of disposable medical products for dialysis treatments. With a dedicated team of more than 3,000 employees across four manufacturing sites, the plant focuses on manufacturing essential components such as hemodialysis disposables, peritoneal dialysis (PD) disposables, hemodialysis (HD) machines, and PD cycler machines.

By utilizing advanced technologies to ensure the highest standards in dialysis product manufacturing, we’re not only driving innovation—we’re also creating meaningful change for patients worldwide. Join our passionate team and be part of this global impact.

The Quality Engineer I supports product and process quality activities to ensure medical devices meet applicable quality, design control, validation, risk management, and regulatory requirements, working with cross-functional teams throughout the product life cycle.

•Support customer complaints, Nonconformances (NC), CAPA, Root Cause Analysis, and corrective/preventive actions.

•Support product/process validations, test method development, specifications, design reviews, qualification, Design Controls, and Design Transfer.

•Perform statistical analysis using DOE, Correlation & Regression, Acceptance Sampling, Gage R&R, Process Capability Studies, control charts, flow charts, scatter diagrams, and histograms.

•Apply statistical inference and Binomial, Poisson, Normal, and Exponential distributions.

•Support manufacturing process, product, and quality improvements, including engineering changes, cost-saving projects, and Change Control.

•Apply Risk Management techniques throughout the product life cycle.

•Ensure compliance with applicable cGMP, FDA, ISO, and MDD requirements, including required quality/regulatory documentation, customer complaint samples, and FIRs.

•Support internal and external audits, including observations and corrective actions.

•Collaborate with internal, cross-functional, and cross-site teams on quality initiatives, while managing assigned project priorities, objectives, deliverables, and timelines.

•Bachelor’s degree in Engineering, preferably Mechanical, Industrial, Electrical, Electromechanical, Biomedical, or equivalent.

•Minimum 2 years of experience in Quality Engineering or a related field; Medical Device experience preferred.

•Experience or knowledge in CAPA, NC, Root Cause Analysis, product/process validation, Risk Analysis, Process Capability, test methods, and statistical quality tools.

•Knowledge of DOE, Gage R&R, Correlation & Regression, Acceptance Sampling, Six Sigma, cGMP, FDA, ISO, and MDD.

•Strong technical, analytical, mathematical, problem-solving, computer, and communication skills, with the ability to present information to upper management and other groups.

•Ability to develop and implement methods and use statistical tools to identify process behavior and resolve quality issues.

•Customer-focused quality approach.

•Bilingual English / Spanish.

•U.S. Visa required.

There is a lot you can discover at Fresenius Medical Care, regardless of the field of expertise or level of experience—everything is dedicated to supporting your professional journey.

• Whether in front of or behind the scenes, you help make better medicine available to more people worldwide
• Individual opportunities for self‑determined career planning and professional development
• A corporate culture that encourages innovative thinking—finding the best solution together, not just the fastest one
• A team of committed professionals with diverse skills, talents, and experiences
• The strength of a successful global corporation combined with the collegial culture of a mid‑sized company.