Quality Engineering Manager

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

Job summary

Fresenius Medical Care operates a plant in Antalya, Turkey, focused on manufacturing high‑quality dialysis components. We seek a senior Quality Engineer to lead cross‑site quality initiatives, manage CAPA, and drive improvements in process validation and regulatory compliance.

The role requires a Bachelor’s in Engineering, 5+ years in regulated manufacturing, strong English, and 8D/DMAIC problem‑solving expertise. Willingness to travel and relocate to Antalya is essential.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Industrial, Electronics, Manufacturing, or related)
• 5+ years in Manufacturing/Process Engineering in regulated medical device environment, incl. 3 years in leadership
• Excellent command of English (oral & written)
• Strong knowledge of medical device quality systems and regulations (ISO 13485, EU MDR, FDA 21 CFR Part 820, ISO 14971, MDSAP)
• Experience leading complex quality investigations, CAPA, root cause analysis, and quality improvement initiatives
• Hands-on with manufacturing risk management, PFMEA, process validation, and tech/design transfer
• Lean Six Sigma Green/Black Belt preferred
• Leadership & cross-functional collaboration skills; willingness to travel (domestic/international)
• Resident of Antalya or willing to relocate

Responsibilities

• Lead and standardize Quality Engineering activities across multiple manufacturing sites producing medical devices.
• Drive investigations and resolutions of complex product and process quality issues using structured methods (8D, DMAIC, RCA, FMEA, stats).
• Provide technical leadership for CAPA, nonconformance, deviation, and investigation processes with effective corrective actions.
• Analyze quality data, complaints, process performance, and trends to identify systemic issues and improvements.
• Support customer complaint investigations with cross-functional teams to determine root causes.
• Lead cross-functional teams (Quality, Manufacturing, Engineering, Operations, Supply Chain, Regulatory) to drive quality improvements.
• Support new product introductions, design transfers, manufacturing transfers, and process changes with risk mitigation in mind.
• Participate in risk management activities including PFMEA, validation strategies, and process controls.
• Drive continuous improvement for defect prevention, robustness, yield, and operational excellence.
• Ensure compliance with ISO 13485, EU MDR 2017/745, FDA regulations, ISO 14971, and other regulatory requirements.
• Support audits and provide expertise on quality systems, investigations, CAPA, and process controls.
• Establish standardized Quality Engineering practices and monitor quality performance metrics.

Skills

Quality leadership

CAPA investigations

Root cause analysis

Statistical analysis

Regulatory knowledge

Process validation

Lean Six Sigma

Cross-functional collaboration

Travel willingness

English proficiency

Education

Bachelor’s degree in Engineering

Tools

Minitab

CAPA management tools

Job description

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 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 Antalya plant in Turkey, we focus on the production of high-quality components used in dialysis therapy, including bloodlines, tubing systems, and accessories. With a dedicated team of 1,600 employees, our facility utilizes advanced technologies such as bloodline assembly, automated sub-assembly, extrusion, injection molding, and ETO sterilization. This site plays a vital role in Fresenius Medical Care’s commitment to enhancing patient care worldwide. Join our passionate team and be part of this global impact!

REQUIRED QUALIFICATIONS

• Bachelor’s degree in Engineering (Mechanical, Industrial, Electronics, Manufacturing, or a related field)
• Minimum 5 years of experience in Manufacturing or Process Engineering within a regulated medical device environment, including at least 3 years in a leadership position
• Excellent command of English, both oral and written
• Strong knowledge of medical device quality systems and regulations, including ISO 13485, EU MDR, FDA 21 CFR Part 820, ISO 14971, and MDSAP
• Proven experience leading complex manufacturing investigations, CAPA activities, root cause analysis, and quality improvement initiatives
• Hands‑on experience with manufacturing risk management, PFMEA, process validation, and technology/design transfer projects
• Strong analytical and statistical problem‑solving skills; experience with Minitab or similar statistical software is preferred
• Knowledge of manufacturing technologies such as injection molding, extrusion, automation, assembly, bonding, or sealing processes is an advantage
• Lean Six Sigma Green Belt or Black Belt certification is preferred
• Excellent leadership, communication, stakeholder management, and cross‑functional collaboration skills
• Willingness to travel domestically and internationally as required
• Living in Antalya or willing to relocate

KEY RESPONSIBILITIES

• Lead and standardize Quality Engineering activities across multiple manufacturing sites producing medical devices.
• Drive the investigation and resolution of complex product and process quality issues using structured problem‑solving methodologies (8D, DMAIC, Root Cause Analysis, FMEA, statistical analysis, etc.).
• Provide technical leadership for CAPA, nonconformance, deviation, and investigation processes, ensuring effective and sustainable corrective actions.
• Analyze quality data, complaints, process performance, and manufacturing trends to identify systemic issues and improvement opportunities.
• Support customer complaint investigations and collaborate with cross‑functional teams to determine product, process, material, or design‑related root causes.
• Lead cross‑functional teams involving Quality, Manufacturing, Engineering, Operations, Supply Chain, and Regulatory Affairs to drive quality improvements.
• Support new product introductions, design transfers, manufacturing transfers, and process changes while ensuring quality risks are effectively managed.
• Participate in risk management activities, including PFMEA, validation strategies, process controls, and critical quality characteristic assessments.
• Drive continuous improvement initiatives focused on defect prevention, process robustness, yield improvement, and operational excellence.
• Ensure compliance with ISO 13485, EU MDR 2017/745, FDA regulations, ISO 14971, and other applicable regulatory requirements.
• Support internal and external audits and provide technical expertise related to quality systems, investigations, CAPA, and process controls.
• Establish and promote standardized Quality Engineering practices, tools, and best practices across manufacturing sites.
• Develop and monitor quality performance metrics and communicate significant quality risks and improvement opportunities to senior management.

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.