Quality Systems Engineer I (NC-CAPA)

Quality Systems Engineer I (NC-CAPA)

Introduction

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 125,000 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

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.

Systems, Quality & Regulatory (SQR)

Systems, Quality & Regulatory (SQR) is a global function within Care Enablement that ensures Fresenius Medical Care’s products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle. The team supports market access, innovation, and patient safety by driving excellence across manufacturing and supply chain operations, overseeing post-market surveillance, and promoting continuous improvement and system harmonization. SQR also manages regulatory and quality data governance and provides critical product-related business services across global operations.

Join our passionate team and help shape healthcare worldwide!

About the Role

As a Quality Systems Engineer I (NC‑CAPA), you will support site quality initiatives and compliance objectives by contributing to quality systems, investigations, validations, and continuous improvement activities. Under close supervision, you will apply established procedures to ensure compliance with FDA, cGMP, and Quality System Regulations while supporting manufacturing operations and product quality.

Your Responsibilities

• Support the development, review, and continuous improvement of the facility Quality Plan, manufacturing processes, and Quality System procedures.
• Participate in the management and maintenance of Risk Management Files and support information exchange across facilities.
• Prepare, review, and assist in the execution of process validations (IQ, OQ, PQ), validation protocols, final reports, and Engineering Change Orders (ECOs).
• Maintain validation records to ensure ongoing compliance and relevance to process changes.
• Perform investigations related to product complaints, nonconformances, and CAPAs, preparing reports for review prior to submission to Corporate Quality.
• Analyze quality data, complaints, and process trends to identify existing or potential causes of failure and support corrective and preventive actions.
• Apply statistical tools (CpK, trend analysis, SPC) to detect recurring issues or negative trends and recommend improvements.
• Review new and existing manufacturing processes to ensure compliance with FDA, cGMP, and QSR requirements while improving quality and productivity.
• Support plant metrology and calibration programs, ensuring inspection and test equipment are available and calibrated on time.
• Participate in internal and external audits as part of the site audit team.
• Assist with internal training related to validations, calibration, production processes, and equipment operation.
• Contribute to design control activities and perform risk analyses (FMEA, FMECA, Fault Tree, HACCP or equivalent).
• Exercise the authority to issue a STOP NOTICE when product quality, compliance, or patient safety may be at risk.

Your Profile

• Bachelor’s degree in Engineering, Science, Chemistry, Biology, or a related field (Associate degree may be considered with additional relevant experience).
• 0-2 years of experience in Quality Engineering, Quality Systems, or Process Validation; experience in medical device, pharmaceutical, or laboratory environments preferred.
• Bilingual English/Spanish.
• Knowledge of FDA regulations (QSR, cGMP, GLP), process validation methodologies, risk management, and statistical process control.
• Experience or exposure to CAPA, nonconformance management, and investigations.
• Strong analytical, organizational, and problem-solving skills; ability to prioritize and work with limited supervision.
• Effective verbal and written communication skills; ability to prepare clear technical reports and presentations.
• Proficiency in Microsoft Office tools.
• Willingness to work flexible schedules (day, night, or weekends, as required).
• U.S. visa required and availability to travel domestically and internationally as needed.
• Certifications such as Six Sigma Green Belt, ASQ, CQE, CQA, or equivalent are a plus.

Our Offer For You

There is a lot you can discover at Fresenius Medical Care, regardless of your field of expertise or level of experience—all dedicated to supporting your professional journey. Whether in front of or behind the scenes, your work helps make better medicine available to more people around the world.

Individual opportunities for career development and self-directed growth.

A corporate culture that values innovation, quality, and doing things right - not just fast collaboration with a diverse, committed global workforce.

The stability and benefits of a successful global corporation with the collegial culture of a medium-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.