Quality Engineering Manager

Fresenius Group; Muratpaşa; On-site; TRY 550,000 - 850,000; Full time

Job summary

Fresenius Medical Care in Antalya, Turkey, seeks a senior Quality Engineer to lead quality activities across sites. You will drive investigations and CAPA, oversee root-cause analyses, and partner with Manufacturing, Engineering, and Regulatory Affairs to implement robust controls.

The role requires extensive medical device quality systems knowledge and global regulatory awareness. The position emphasizes cross-functional leadership, data-driven improvement, and ongoing risk management, with

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Industrial, Electronics, Manufacturing or related field).
• Min 5 years in Manufacturing or Process Engineering in regulated medical device environment, incl. 3+ years in leadership.
• Excellent command of English, both oral and written.
• Strong knowledge of medical device quality systems and regulations (ISO 13485, EU MDR, FDA 21 CFR Part 820, ISO 14971, MDSAP).
• Proven experience leading complex quality investigations, CAPA and root cause analysis.
• Hands-on with risk management, PFMEA, process validation and tech transfer.
• Lean Six Sigma Green Belt or Black Belt preferred.
• Willing to travel domestically and internationally; living in Antalya or willing to relocate.

Responsibilities

• Lead Quality Engineering activities across multiple manufacturing sites producing medical devices.
• Drive investigation and resolution of complex product and process quality issues using structured problem-solving methodologies (8D, DMAIC, RCA, FMEA, statistics).
• Provide technical leadership for CAPA, nonconformance, deviation, and investigation processes with effective corrective actions.
• Analyze quality data, complaints, process performance, and manufacturing trends to identify systemic issues and improvements.
• Support customer complaint investigations and collaborate with cross-functional teams to determine 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 with risk management.
• Participate in risk management activities, PFMEA, validation strategies, process controls, and critical quality characteristic assessments.
• Drive continuous improvement initiatives focused on defect prevention, process robustness, yield, and excellence.
• Ensure compliance with ISO 13485, EU MDR 2017/745, FDA regulations, ISO 14971, and other regulatory requirements.
• Support 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 sites.
• Develop and monitor quality performance metrics and communicate risks to senior management.

Skills

Quality management

Root cause analysis

CAPA

Statistical analysis

Cross-functional collaboration

English proficiency

Problem solving

Leadership

Risk management

Minitab

Regulatory awareness

Education

Bachelor’s degree in Engineering

Tools

PFMEA

CAPA system

Minitab

Process validation

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.