Global Quality Engineering Lead, Medical Devices

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

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