Quality Engineer - Process Excellence & CAPA Lead

Fresenius Group; Muratpaşa; On-site; TRY 300,000 - 520,000; Full time

Job summary

Fresenius Medical Care in Antalya, Turkey, seeks a Quality/ Manufacturing Engineer focused on quality engineering within a regulated medical device environment. You will investigate quality issues, drive CAPA, analyze data, and collaborate with cross-functional teams.

The ideal candidate holds a Bachelor's in engineering and 3+ years in a regulated setting; ISO 13485/14971 familiarity is preferred. Willingness to travel and relocation to Antalya may be required.

Qualifications

• Bachelor's degree in engineering or related technical discipline.
• 3+ years in Quality/Manufacturing/Process Engineering in regulated manufacturing.
• Experience with nonconformance management, CAPA, root cause analysis, investigations, corrective actions.
• Familiarity with ISO 13485 and ISO 14971 preferred.
• Experience with quality tools (SPC, Pareto, trend analysis).
• Proficiency in MS Office and data interpretation; travel as required.

Responsibilities

• Investigate and resolve quality issues using structured problem-solving methodologies (8D, 5 Why, Fishbone).
• Support CAPA, nonconformance, deviation, and corrective action activities.
• Analyze quality and manufacturing data to identify trends and opportunities for improvement.
• Provide technical support for customer complaint investigations with cross-functional teams.
• Apply SPC, process capability analysis, Pareto, and trend analysis to support decisions.
• Participate in continuous improvement and manufacturing transfer projects.
• Collaborate with Manufacturing, Process Engineering, Operations, Regulatory, and Quality teams.

Skills

Analytical thinking

Problem solving

Data interpretation

Communication skills

Cross-functional collaboration

Minitab

Microsoft Office

Willingness to travel

Travel readiness

Education

Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Electrical & Electronics Engineering, Chemical Engineering, Industrial Engineering, Materials Science, or related technical discipline

Tools

Minitab

Job description

Fresenius Medical Care in Antalya, Turkey, seeks a Quality/ Manufacturing Engineer focused on quality engineering within a regulated medical device environment. You will investigate quality issues, drive CAPA, analyze data, and collaborate with cross-functional teams.

The ideal candidate holds a Bachelor's in engineering and 3+ years in a regulated setting; ISO 13485/14971 familiarity is preferred. Willingness to travel and relocation to Antalya may be required.