Quality System Engineer

Quality System Engineer

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.

Our manufacturing plant in Guadalajara, Mexico plays a key role in our global operations. The site specializes in the production of HD Liquid Acids, Diluted Solution for Hemodialysis, Bicarbonate Solution, Peritoneal Dialysis, and Sodium Citrate—primarily for export to the United States and Canada. With over 700 employees, the site also supports Product and Process Development, as well as Sustaining Engineering, contributing to the continuous improvement of our therapies and ensuring high-quality standards across our product portfolio. Join our passionate team and be part of this global impact!.

As a Quality System Engineer, you will support Quality Operations by ensuring compliance with quality system, regulatory, and corporate requirements. The role is responsible for reviewing manufacturing and quality records, managing product disposition activities, maintaining quality documentation, supporting batch release processes, and driving continuous improvement initiatives.

Responsibilities

• Review and disposition finished product and plastic bag batch records.
• Monitor and control finished product lots, including product disposition activities in SAP.
• Verify compliance with parametric release requirements for saline solutions, including export products.
• Review environmental monitoring, water system monitoring, raw material inspection, manufacturing execution, and receiving records.
• Review nonconformances and deviations to ensure quality requirements are met prior to product release or rejection.
• Administer the containment hold system and support batch release activities.
• Maintain, update, and ensure compliance of Quality System procedures with applicable regulations and corporate requirements.
• Organize, maintain, and safeguard Quality Technical Archive documentation.
• Prepare and update procedures supporting departmental activities.
• Comply with site and corporate procedures, policies, safety regulations, and training requirements.
• Participate in continuous improvement initiatives within Quality Operations.

Qualifications

• Bachelor’s Degree in Chemistry, Pharmaceutical Sciences, Industrial Engineering, Chemical Engineering, or a related field.
• 1 year of experience in a similar position.
• Knowledge of Statistical Process Control (SPC).
• Knowledge of ISO 13485, 21 CFR Parts 210, 211, and 820, and NOM-241-SSA1.
• Proficiency in Microsoft Office applications.
• Knowledge of Quality Systems.
• Knowledge of SAP or similar ERP systems.
• Intermediate English.
• Adherence to established guidelines and procedures.
• Learning agility and capacity to acquire new knowledge.
• Strong interpersonal skills.
• Results-oriented with a focus on achieving goals.
• Problem-solving skills with the ability to develop alternatives and solutions.
• Ability to work under pressure.
• Teamwork and collaboration to achieve results.

Our Offer for You

There is a lot you can discover at Fresenius Medical Care, regardless of your background or level of experience—all dedicated to your professional journey.

• Whether in front of or behind the scenes, you are helping make ever better medicine available to more people around the world.
• Individual opportunities for career development and professional growth.
• A culture that encourages innovative thinking and collaboration.
• The opportunity to work alongside talented and committed professionals.
• The benefits of a successful global corporation combined with the collegial culture of a medium-sized company.