Quality Engineering Leader – Medical Devices

Fresenius Medical Care; Muratpaşa; On-site; TRY 400,000 - 700,000; Full time

Job summary

Fresenius Medical Care in Antalya, Turkey, leads production of components for dialysis therapy at a 1,600-employee facility using advanced processes. We seek a senior Quality Engineer/Leader to drive CAPA, investigations, and quality improvements across multiple sites, ensuring compliance with ISO 13485, EU MDR, and FDA requirements.

Ideal candidate has 5+ years in regulated manufacturing, strong English, and relocation willingness to Antalya; travel domestically and internationally may be

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Industrial, Electronics, Manufacturing, or related field).
• Minimum 5 years in Manufacturing or Process Engineering within a regulated medical device environment, including 3+ years in leadership.
• 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.
• Lean Six Sigma Green Belt or Black Belt certification 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.

Responsibilities

• Lead and standardize Quality Engineering activities across multiple manufacturing sites producing medical devices.
• Drive investigations and resolution of complex product and process quality issues using structured problem-solving methodologies (8D, DMAIC, RCA, FMEA, etc.).
• Provide technical leadership for CAPA, nonconformance, deviation, and investigation processes.
• Analyze quality data, complaints, process performance and manufacturing trends to identify systemic issues.
• 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 improvements.
• Support new product introductions, design transfers, manufacturing transfers, and process changes with risk management.
• Participate in risk management activities, including PFMEA, validation strategies, and control plans.
• Drive continuous improvement focused on defect prevention, robustness, yield, and operational excellence.
• Ensure compliance with ISO 13485, EU MDR 2017/745, FDA regulations, ISO 14971 and other applicable requirements.
• Support internal and external audits and provide expertise related to quality systems, investigations, CAPA and process controls.
• Establish standardized Quality Engineering practices, tools and best practices across sites.
• Develop and monitor quality performance metrics and communicate risks and opportunities to senior management.

Skills

Leadership

Quality engineering

Problem solving

CAPA

Root cause analysis

PFMEA

Statistical analysis

Minitab

Cross-functional collaboration

Travel willingness

Relocation readiness

English proficiency

Education

Bachelor's degree in Engineering (Mechanical, Industrial, Electronics, Manufacturing, or related field)

Tools

Minitab

Statistical software

Job description

Fresenius Medical Care in Antalya, Turkey, leads production of components for dialysis therapy at a 1,600-employee facility using advanced processes. We seek a senior Quality Engineer/Leader to drive CAPA, investigations, and quality improvements across multiple sites, ensuring compliance with ISO 13485, EU MDR, and FDA requirements.

Ideal candidate has 5+ years in regulated manufacturing, strong English, and relocation willingness to Antalya; travel domestically and internationally may be