Quality Engineer II

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 visionCreating a future worth living. For patients. Worldwide. Every work with purpose and compassion supported by a global team of over 110000 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 waygrowing 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 3000 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 were not only driving innovationwere 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

Bachelors 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 experienceeverything 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 selfdetermined career planning and professional development
A corporate culture that encourages innovative thinkingfinding 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 midsized company.