Quality Engineer II

Quality Engineer II- NAMD

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

As a Quality Engineer II for Non-Active Medical Devices (NAMD), you will be responsible for supporting Quality and Engineering activities related to product, process, and quality improvements, while providing technical expertise for the Risk Management and Corrective and Preventive Action (CAPA) systems.

You will support the development, evaluation, monitoring, reporting, and implementation of corrective and preventive actions, contributing to effective Risk Management, regulatory compliance, and continuous improvement.

Your Responsibilities:

• Ensure the Risk Management System remains adequate, suitable, and effective.
• Implement and provide technical expertise in support of the Risk Management Program.
• Ensure Risk Management procedures are properly implemented.
• Develop and maintain Risk Management Files in accordance with ISO 14971 and other applicable regulations and standards.
• Review and approve relevant Risk Management documentation.
• Provide updates on Risk Management processes and Risk Management Files for Management Reviews.
• Provide technical expertise and review and approve relevant Design Control documentation.
• Review and support risk assessments associated with design and process changes.
• Monitor manufacturing and Quality System processes to evaluate their potential impact on Risk Management Files.
• Complete applicable risk review reports associated with annual Risk Management File reviews and provide technical support for risk reviews as required.
• Lead and train personnel on Risk Management System activities as needed.
• Serve as CAPA System Administrator, including:

• • Control and maintenance of the CAPA system and supporting documentation, forms, and records.
  • Facilitation of each stage of the CAPA process.
  • Review and challenge of root cause analysis during investigations.
  • Maintenance of CAPA project progress documentation.
  • Follow-up on compliance with CAPA activity schedules.

• Support responses to internal and external audit observations and corrective actions related to Risk Management.
• Create CCNs and CCRs.
• Provide technical support to Engineering for process, product, quality, and control improvements.

Your Profile:

• Bachelor’s degree in Engineering or equivalent experience.
• Minimum 3 years of experience in Quality Engineering, Quality Assurance, or similar areas supporting manufacturing processes; medical device experience preferred.
• Experience and technical knowledge in Risk Management.
• Experience with ISO 14971 and ISO 13485.
• Experience with CAPA, root cause analysis, and corrective and preventive actions.
• Strong technical and analytical skills.
• Excellent interpersonal, verbal, and written communication skills.
• Bilingual English/Spanish, with excellent English communication skills.
• Valid U.S. visa 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 global corporation combined with the collegial culture of a mid‑sized company.