Quality Engineer II
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 II
is responsible for supporting quality systems, compliance objectives, risk management, and validation activities to ensure product quality, regulatory compliance, and continuous improvement within a regulated manufacturing environment.
Your Responsibilities:
Support quality initiatives, compliance objectives, and quality planning activities
Participate in internal and external audits as a member of the site Audit Team
Support design control activities for new and existing products
Conduct risk assessments using FMEA, FMECA, Fault Tree Analysis, Hazard Analysis, and equivalent methodologies
Lead and support process and test method validations, including IQ, OQ, and PQ activities
Develop and maintain quality documentation, including procedures, SOPs, ETRs, drawings, equipment specifications, and technical reports
Perform root cause analysis, process capability studies, and continuous improvement activities
Conduct and interpret statistical analyses including DOE, Correlation & Regression, Acceptance Sampling, and Gage R&R; studies
Ensure compliance with corporate, state, federal, and regulatory requirements
Support cross-functional quality projects and travel as required for audits, validations, training, and process-related activities




Your Profile
Bachelor's degree in mechanical, Electrical, Electromechanical, Biomedical, or related Engineering field.
Advanced degree preferred
2-5 years of experience in Quality Engineering, Medical Device Manufacturing, Pharmaceutical Manufacturing, and/or Laboratory environments
Strong technical, analytical, and problem-solving skills
Experience with Process Validation (IQ/OQ/PQ), Root Cause Analysis, Risk Analysis, DOE, Process Capability Studies, and Gage R&R;
Knowledge of manufacturing processes, SOPs, engineering drawings, equipment specifications, and testing methods
Proficiency in Minitab, SAP, and Microsoft Office
Strong technical writing and presentation skills
Bilingual (English/Spanish)
U.S. Visa required
Availability to travel domestically and internationally
German language proficiency is preferred but not required
Our Offer for You
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 general corporation combined with the collegial culture of a mid‐sized company.
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📌 Quality Engineer Ii (Reynosa)
🏢 Fresenius Medical Care
📍 Reynosa