Senior Quality Engineer for Non-AMD

CH01 CHE Fresenius Medical Care (Schweiz) AG; Reynosa; On-site; MXN 600,000 - 900,000; Full time

Benefits offered by this job

Career development

Diverse team environment

Global medical devices company

Job summary

Fresenius Medical Care Reynosa plant seeks a Senior Quality Engineer for Non-Active Medical Devices. You will act as SME for manufacturing quality, leading CAPA investigations, risk assessments, and design transfers to ensure product reliability.

The role requires 3–5 years in regulated medical devices, strong QA tools knowledge, and leadership across cross-functional teams. ISO 13485 and FDA Part 820 experience are essential.

Qualifications

• Bachelor’s degree in Electronic, Mechanical, Industrial Engineering or related field.
• 3–5 years in Quality/Manufacturing Engineering in regulated medical devices.
• Experience leading complex quality investigations and CAPA resolution.
• Experience with design transfer from R&D to manufacturing.
• Experience with PFMEA, risk assessments and data analysis.
• Knowledge of SPC, MSA, DOE, ANOVA and probability analysis.
• Experience with process validation and TMV.
• Lean Manufacturing and Six Sigma tools familiar.
• Strong quality system knowledge: ISO 13485, FDA 21 CFR Part 820, MDSAP.
• Supplier quality management and CAPA systems exposure.
• Advanced English required; US visa may be required.

Responsibilities

• Act as SME in Manufacturing Quality Engineering for NAMD.
• Analyze quality trends, process capability, and defect patterns.
• Lead quality risk assessments and improvement opportunities.
• Provide technical leadership to cross-functional teams.
• Lead root cause investigations involving CAPAs and defects.
• Drive structured problem solving (8D, DMAIC, statistics).
• Evaluate CAPA effectiveness through trend analysis.
• Support design transfer activities for manufacturing readiness.
• Participate in design reviews and risk assessments.
• Review technical documents: drawings, specs, test methods.
• Lead or support validation activities: TMV, equipment qualification, MSA.
• Ensure documentation aligns with regulatory requirements.
• Identify systemic quality issues and drive improvements.
• Support PFMEA updates and risk management activities.
• Collaborate with multiple departments and sites.

Skills

Quality engineering

CAPA leadership

Root cause analysis

Design transfer

PFMEA

Process capability

SPC

DOE

Minitab

Lean Six Sigma

ISO 13485 knowledge

FDA 21 CFR Part 820

MDSAP

Supplier quality

Quality audits

Education

Bachelor's Degree in Electronic/Mechanical/Industrial Engineering

Tools

Minitab

ERP/MES

Job description

Senior Quality Engineer for Non-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 a Senior Quality Engineer for Non-Active Medical Devices (NAMD), you will be responsible for ensuring product and manufacturing process quality by providing advanced manufacturing quality engineering expertise. You will act as a technical Subject Matter Expert (SME), supporting complex and systemic quality investigations, CAPA and nonconformance resolution, design transfer, validation, risk management, and continuous improvement activities.

Your Responsibilities

• Act as a technical Subject Matter Expert (SME) in Manufacturing Quality Engineering for Non-Active Medical Devices (NAMD).
• Analyze manufacturing quality trends, process capability data, and defect patterns to identify systemic issues affecting product performance or reliability.
• Lead technical walkthroughs and quality risk assessments within manufacturing areas to proactively identify quality risks and improvement opportunities.
• Provide technical leadership to cross-functional teams addressing complex manufacturing quality challenges.
• Lead complex root cause investigations involving escalated CAPAs, recurring manufacturing defects, significant nonconformances, and field complaints linked to manufacturing processes.
• Drive structured problem-solving activities using methodologies such as 8D, DMAIC, statistical analysis, and failure analysis techniques.
• Evaluate CAPA effectiveness through trend analysis and process performance monitoring.
• Provide technical leadership during design transfer activities, ensuring manufacturing readiness and process capability.
• Participate in design reviews, risk assessments, and engineering change evaluations impacting manufacturing quality.
• Review and approve relevant technical documentation, including drawings, specifications, test methods, and risk analyses.
• Lead or technically support process validation, Test Method Validation (TMV), equipment qualification, and Measurement System Analysis (MSA).
• Ensure validation activities comply with regulatory and quality system requirements.
• Identify systemic manufacturing quality issues and lead improvement initiatives focused on product reliability, reduction of Cost of Poor Quality, and manufacturing process capability.
• Lead or support manufacturing risk management activities, including PFMEA development and updates.
• Evaluate risks associated with manufacturing processes, engineering changes, and quality investigations.
• Provide technical expertise during internal and external audits related to manufacturing quality investigations and systemic quality issues.
• Ensure engineering-driven quality activities support compliance with ISO 13485, FDA 21 CFR Part 820, and MDSAP.
• Collaborate closely with Manufacturing Engineering, Product Engineering/R&D, Operations, and Supplier Quality, including cross-site investigations when advanced technical expertise is required.

Your Profile

Bachelor's Degree in Electronic, Mechanical, Industrial Engineering, or a related engineering field. 3-5 years of experience in Quality Engineering or Manufacturing Engineering within regulated medical device and manufacturing environments, preferably involving Non-Active Medical Devices (NAMD) or manufacturing processes of comparable complexity. Demonstrated experience leading complex manufacturing quality investigations. Experience with CAPA and systemic quality issue resolution. Experience with design transfer activities from R&D to Manufacturing. Experience with manufacturing risk assessments and PFMEA. Experience with process capability and statistical data analysis. Experience with process validation and Test Method Validation (TMV). Knowledge of Statistical Process Control (SPC), Measurement System Analysis (MSA), Design of Experiments (DOE), ANOVA, and probability analysis. Experience with Lean Manufacturing and Six Sigma tools. Strong knowledge of medical device quality systems, including ISO 13485, FDA 21 CFR Part 820, and MDSAP. Experience with supplier quality management and CAPA systems. Advanced English U.S. Visa required. Intermediate/advanced proficiency in Microsoft Office, statistical software (Minitab preferred), ERP/MES, and Quality Management Systems. Preferred certifications: Lead Auditor, Certified Quality Engineer (CQE), and Six Sigma Green Belt or Black Belt. Strong technical leadership, decision-making, technical presentation, and cross-functional communication skills.

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.