Quality Specialist 3

Senior PD Quality Engineer

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 Senior PD Quality Engineer , you will be responsible for providing engineering support to ensure the quality and reliability of finished products and subassemblies. You will support the development and implementation of process, product, quality, and control improvements, applying statistical techniques, validation methodologies, and structured problem-solving tools to identify process behaviors, resolve quality issues, and drive continuous improvement.

Your Responsibilities:

- Develop and implement test methods for medical devices and equipment.
- Support the evaluation and investigation of customer complaints and the development of corresponding Corrective and Preventive Actions (CAPA) for the PD area.
- Monitor internal Nonconformances (NC) and support the development of corrective and preventive actions as part of multidisciplinary teams.
- Perform risk assessments to support the PD Manufacturing area in the closure of Nonconformances.
- Conduct regular walkthroughs throughout the manufacturing area with the PD team to identify and participate in quality improvement projects and investigations.
- Support product and process validations, including preparation of validation protocols when required.
- Apply appropriate statistical techniques to evaluate and analyze products and processes, supporting continuous improvement.
- Support regulatory compliance with applicable cGMP requirements and medical device regulations, including FDA, ISO, and MDD requirements.
- Provide appropriate documentation and technical analysis related to customer complaint samples and FIRs when required.
- Support plant areas during product transfers, engineering changes, and specification changes.
- Participate in conference calls, technical presentations, and meetings with plant teams and management when required.
- Maintain communication with Corporate Quality Engineering/PSS, Canada, and other FME sites regarding CAPAs, quality improvement projects, and customer complaints when required.
- Maintain required training according to the assigned curriculum and remain current with applicable process and documentation changes.
- Support responses to internal audit observations and corrective actions.
- Review and approve drawings and fixtures.
- Review and approve Instrument Specification Sheets (ISS).
- Support new Design Transfer activities.
- Develop and implement new methods and apply statistical tools to resolve quality problems and identify process behavior.
- Support the development of test methods for electronic devices and Poka-Yoke mechanisms.
- Perform process capability studies.
- Maintain a customer-focused approach to Quality.

Your Profile:

- Bachelor’s degree in Electronic Engineering, Mechatronic Engineering, or a related engineering discipline.
- Minimum 2 years of experience in Quality Engineering or Manufacturing Engineering; medical device experience preferred.
- Experience with problem-solving and Root Cause Analysis.
- Knowledge of Six Sigma methodology.
- Experience with process validation and physical test method validation.
- Experience applying statistical tools to product and process analysis.
- Knowledge or experience in process capability studies.
- Experience supporting product/process quality improvements and controls.
- Strong technical and analytical skills.
- Excellent interpersonal, verbal, and written communication skills.
- Bilingual English/Spanish.
- Proficiency with Minitab and Microsoft Office, including Excel and Word.
- 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.