Advanced Manufacturing Quality Engineer – Active Medical Devices

CH01 CHE Fresenius Medical Care (Schweiz) AG; Reynosa; On-site; MXN 480,000 - 720,000; Full time

Job summary

Fresenius Medical Care in Reynosa is seeking an Advanced Manufacturing Quality Engineer for Active Medical Devices. You will provide technical Quality Engineering support to manufacturing processes and collaborate with cross-functional teams to ensure compliance and product quality.

The role requires a Bachelor’s degree in engineering, 3+ years in quality/manufacturing engineering in regulated environments, experience with CAPA, nonconformance, process validation, and statistical analysis.

Qualifications

• Bachelor’s degree in engineering; 3+ years in quality/manufacturing engineering in regulated environments.
• Experience in active medical device manufacturing or electronics is preferred.
• Strong root cause analysis and nonconformance management capabilities.
• Knowledge of CAPA processes, PFMEA, and quality investigations.
• Familiarity with ISO 13485 and FDA QSR requirements.
• Proficient with statistical tools and basic process validation concepts.

Responsibilities

• Provide technical Quality Engineering support to manufacturing processes for active medical devices.
• Analyze quality data and process trends to identify issues and improvement opportunities.
• Lead technical walkthroughs to identify quality risks and optimization steps.
• Support cross‑functional teams during investigations and CAPA implementation.
• Lead root cause investigations for nonconformances and deviations.
• Assist in design transfer, design reviews, and engineering change evaluations.
• Review manufacturing procedures, test methods, and related documentation.
• Support process validation, measurement systems analysis, and quality improvements.

Skills

Quality engineering

Root cause analysis

CAPA investigations

Cross-functional problem-solving

Statistical analysis

Process validation

Manufacturing risk management

ISO 13485 knowledge

FDA QSR knowledge

Minitab

Education

Bachelor’s degree in Electronic, Mechanical, Industrial Engineering or related field

Master’s degree in Engineering or Quality Systems

Tools

Minitab

ERP/MES systems

Quality Management Systems

Job description

Advanced Manufacturing Quality Engineer – Active Medical Devices

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:

• Provide technical Quality Engineering support to manufacturing processes for Active Medical Devices.
• Analyze manufacturing quality data and process trends to identify potential quality issues and improvement opportunities.
• Participate in technical walkthroughs of manufacturing areas to identify potential quality risks and process improvement opportunities.
• Support cross‑functional teams during quality investigations and improvement initiatives.
• Support root cause investigations for manufacturing nonconformances, deviations, and CAPA investigations.
• Apply structured problem‑solving methodologies, including 5 Why Analysis, Fishbone/Ishikawa Analysis, and basic statistical analysis.
• Support containment, correction, and corrective action implementation during quality investigations.
• Support Quality Engineering activities during product design transfer from development to manufacturing.
• Participate in design reviews and engineering change evaluations.
• Assist in reviewing relevant technical documentation, including manufacturing procedures and test methods.
• Support Process Validation, Test Method Validation, and Measurement System Analysis (MSA) activities associated with quality investigations and manufacturing improvements.
• Support manufacturing quality improvement initiatives aimed at reducing defects and improving process capability.
• Participate in cross‑functional continuous improvement projects related to manufacturing quality.
• Support manufacturing risk management activities, including PFMEA updates and manufacturing process risk assessments.
• Support compliance with applicable regulatory and Quality System requirements, including ISO 13485 and FDA QSR.
• Participate in internal audits and regulatory readiness activities when required.
• Collaborate effective with Manufacturing, Engineering, Quality, and other cross‑functional teams.

Your Profile:

• Bachelor’s Degree in Electronic, Mechanical, Industrial Engineering, or a related engineering field.
• Minimum 3 years of experience in Quality Engineering, Manufacturing Engineering, or related technical roles within regulated manufacturing environments.
• Experience in Active Medical Device manufacturing or electronic systems integration is preferred.
• Demonstrated experience supporting Manufacturing quality investigations.
• Root cause analysis for manufacturing defects.
• Nonconformance management.
• CAPA investigations.
• Cross‑functional problem‑solving.
• Manufacturing process improvement initiatives.
• Medical device quality systems.
• Manufacturing risk management.
• Process Validation activities.
• Statistical analysis of manufacturing data.
• Knowledge of product inspection and quality evaluation, sampling techniques, and nonconforming product control.
• Knowledge of Quality System fundamentals, including ISO 13485 and FDA QSR.
• Knowledge of root cause analysis methodologies, including 5 Why and Fishbone/Ishikawa.
• Knowledge of basic Process Validation and statistical tools.
• Intermediate/advanced proficiency in Microsoft Office, statistical software (Minitab preferred), ERP/MES systems, and Quality Management Systems.
• Advanced English.
• Valid U.S. visa required.

Preferred qualifications/certifications:

• Master’s Degree in Engineering or Quality Systems.
• Lead Auditor.
• Quality Engineer / Certified Quality Engineer (CQE).
• Six Sigma Green Belt or Black Belt.

Our Offer for You

• 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.