Quality Engineer II

Fresenius Medical Care AG; Reynosa; Sur place; MXN 420 000 - 660 000; Plein temps

Résumé du poste

Fresenius Medical Care Reynosa plant is seeking a Quality Engineer II to support quality systems and validation in a regulated manufacturing environment for dialysis disposables and related products.

The role focuses on audits, design control, risk assessment, process validation (IQ/OQ/PQ), data analysis, and continuous improvement, collaborating with cross-functional teams to ensure product quality and regulatory compliance.

Qualifications

• Bachelor’s degree in mechanical, electrical, electromechanical, biomedical, or related engineering field.
• 2-5 years of experience in Quality Engineering, Medical Device Manufacturing, Pharmaceutical Manufacturing, or related labs.
• Experience with process validation (IQ/OQ/PQ), RCA, risk analysis, DOE, and Gage R&R.
• Proficiency in Minitab, SAP, and Microsoft Office.
• Bilingual English/Spanish; US visa required; willingness to travel domestically and internationally.

Responsabilités

• Support quality initiatives, compliance objectives, and quality planning activities.
• Participate in audits as a member of the site Audit Team.
• Support design control for new and existing products.
• Conduct risk assessments using FMEA, FMECA, Fault Tree Analysis and Hazard Analysis.
• Lead and support process and test method validations (IQ, OQ, PQ).
• Develop and maintain quality documentation (SOPs, ETRs, drawings, specs, reports).
• Perform root cause analysis, process capability studies, and continuous improvement.
• Conduct and interpret statistical analyses including DOE, correlation and regression, acceptance sampling, and Gage R&R.
• Ensure compliance with regulatory requirements.
• Support cross-functional quality projects and travel for audits/ validations.

Connaissances

Process validation

Root cause analysis

Risk analysis

DOE (Design of Experiments)

Gage R&R

Analytical problem-solving

Technical writing

Presentation skills

Bilingual English/Spanish

Willingness to travel

Formation

Engineering degree (Mechanical / Electrical / Electromechanical / Biomedical)

Outils

Minitab

SAP

Microsoft Office

Description du poste

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.

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.