Quality Engineer II

CH01 CHE Fresenius Medical Care (Schweiz) AG; Reynosa; Presencial; MXN 420.000 - 600.000; Jornada completa

Descripción de la vacante

Fresenius Medical Care's Reynosa plant in Mexico is seeking a Quality Engineer II to support quality initiatives and participate in audits, while contributing to design control activities for medical devices. You will conduct risk assessments and drive validation efforts, including IQ/OQ/PQ, and maintain technical documentation.

The role requires 2–5 years in Quality Engineering, strong analytical skills, proficiency with Minitab/SAP, and bilingual English/Spanish abilities with travel

Formación

• Bachelor’s degree in engineering; advanced degree preferred.
• 2–5 years in Quality Engineering or related manufacturing.
• Experience with IQ/OQ/PQ, RCA, Risk Analysis, DOE, CP, and Gage R&R.

Responsabilidades

• Support quality initiatives, compliance objectives, and quality planning.
• Participate in audits as a site Audit Team member.
• Support design control activities for new and existing products.
• Conduct risk assessments using FMEA and related methods.
• Lead and support process and test method validations (IQ/OQ/PQ).
• Develop and maintain quality documentation (SOPs, ETRs, drawings, specs).
• Perform root cause analysis and continuous improvement activities.
• Carry out statistical analyses including DOE, Gage R&R, and regression.
• Ensure compliance with regulatory requirements and support audits.

Conocimientos

Quality engineering

Process validation IQ/OQ/PQ

Root cause analysis

Risk analysis

DOE

Gage R&R

Engineering drawings

Minitab

SAP

Microsoft Office

Technical writing

Bilingual English/Spanish

Travel readiness

Educación

Bachelor's degree in mechanical, electrical, electromechanical, biomedical, or related engineering

Advanced degree preferred

Herramientas

Minitab

SAP

Microsoft Office

Descripción del empleo

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.

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 global corporation combined with the collegial culture of a mid‑sized company

Creating a future worth living. For patients. Worldwide. Every day. 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.