Quality Specialist 3

CH01 CHE Fresenius Medical Care (Schweiz) AG; Reynosa; On-site; MXN 420,000 - 640,000; Full time

Job summary

Fresenius Medical Care is seeking a Senior PD Quality Engineer to ensure the quality and reliability of PD disposables and related products at the Reynosa site. You will use advanced statistical methods, validation approaches, and problem‑solving tools to drive continuous improvement and regulatory compliance.

The role requires collaboration with cross‑functional teams, handling CAPAs, and supporting product transfers and change controls across the PD manufacturing area.

Qualifications

• Bachelor’s degree in Electronic, Mechatronic, or related engineering field.
• Minimum 2 years in Quality Engineering or Manufacturing Engineering; medical device experience preferred.
• Experience with problem-solving and root cause analysis; Six Sigma knowledge desired.
• Experience with process validation and validation of physical test methods.
• Experience applying statistical tools to product and process analysis.

Responsibilities

• Develop and implement test methods for medical devices and equipment.
• Support the evaluation and investigation of customer complaints and the Entwicklung of CAPA for the PD area.
• Monitor internal nonconformances and support corrective and preventive actions in cross-functional teams.
• Perform risk assessments to support the PD Manufacturing area in closing nonconformances.
• Conduct regular walkthroughs in the PD manufacturing area to identify improvement opportunities.
• Support product and process validations, including preparation of validation protocols.
• Apply statistical techniques to evaluate and analyze products and processes for continuous improvement.
• Support regulatory compliance with FDA, ISO, and MDD requirements.
• Review drawings, fixtures, and Instrument Specification Sheets (ISS).
• Support design transfer activities and new methods development.

Skills

Root Cause Analysis

Six Sigma

Statistical tools

Process validation

Minitab

Problem solving

Communication

Bilingual English/Spanish

Education

Electronic/Mechatronic Eng

Tools

MS Office

Minitab

Job description

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

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.

Fresenius Medical Care is the world's leading provider of products and services for individuals with kidney disease of which approximately 4.5 million patients worldwide regularly undergo dialysis treatment. United by a shared purpose of creating a future worth living for chronically and critically ill people, we care for around 292,000 dialysis patients around the globe. In addition, we operate around 35 global production sites to provide products such as dialysis machines, dialyzers, and related disposables. We aim to continuously improve our patients’ quality of life by offering them high-quality products as well as innovative technologies and treatment concepts.