Advanced Manufacturing Quality Engineer – Active Medical Devices

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.

As an Advanced Manufacturing Quality Engineer for AMD , you will be responsible for supporting product and manufacturing process quality by providing technical Manufacturing Quality Engineering expertise. You will support quality investigations, CAPA and nonconformance resolution, design transfer, validation, risk management, regulatory compliance, and continuous improvement activities while collaborating with Manufacturing, Engineering, Quality, and other cross-functional teams.

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 effectively 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.

- Strong problem-solving, analytical thinking, and team collaboration skills.

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.