Quality Engineer II

CH01 CHE Fresenius Medical Care (Schweiz) AG; Reynosa; Presencial; MXN 420.000 - 540.000; Jornada completa

Descripción de la vacante

Fresenius Medical Care is seeking a Quality Engineer II for our Reynosa, Mexico facility to support quality systems and risk management in a regulated manufacturing environment.

The role focuses on design control, risk analyses, process validation, and continuous improvement across disposable products for dialysis. English/Spanish bilingualism is required, with travel as needed.

Formación

• Bachelor's degree in a engineering discipline (Mechanical, Electrical, Electromechanical, Biomedical) or related field.
• 2–5 years of experience in Quality Engineering, Medical Device or Pharmaceutical environments.

Responsabilidades

• 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 (IQ, OQ, PQ).
• Develop and maintain quality documentation (SOPs, ETRs, drawings, equipment specs, reports).
• Perform root cause analysis, process capability studies, and CI activities.
• Conduct and interpret 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 for audits, validations, training.

Conocimientos

Minitab

SAP

Microsoft Office

Bilingual (English/Spanish)

Gage R&R

DOE

Process Validation IQ/OQ/PQ

Root Cause Analysis

Educación

Bachelor's degree in Mechanical, Electrical, Electromechanical, Biomedical, or related Engineering field

Herramientas

SOPs

Engineering drawings

Descripción del empleo

Quality Engineer II page is loaded## Quality Engineer IIremote type: Onsitelocations: Reynosa, TAMPS, MEXtime type: Full timeposted on: Posted Todaytime left to apply: End Date: September 30, 2026 (13 days left to apply)job requisition id: R0268768**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 innovationAt 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.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**- 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.