Quality Engineer – Medical Devices

About the role

Fresenius Medical Care's Systems, Quality & Regulatory (SQR) function is looking for a Quality Engineer in Vršac. Within the Care Enablement segment, the engineer ensures product quality, process reliability and compliance in the manufacturing environment, investigating quality issues, supporting corrective and preventive actions, analysing manufacturing data and driving continuous improvement.

Key responsibilities

• Investigate and resolve product, process and manufacturing quality issues using 8D, 5 Why, Fishbone and root cause analysis.
• Support and execute CAPA, nonconformance, deviation and corrective action activities under the Quality Management System.
• Analyse quality and manufacturing data to identify trends, variation and opportunities for improvement.
• Support customer complaint investigations and use tools such as SPC, process capability, Pareto and measurement system analysis.
• Take part in continuous improvement, new product introductions, design changes, technology transfers and manufacturing transfers.
• Contribute to risk management, including FMEA, process controls, validation and quality planning.
• Ensure compliance with ISO 13485 and ISO 14971 and support internal and external audits.
• Collaborate with Manufacturing, Process Engineering, Operations, Supply Chain, Regulatory Affairs and Quality teams.

Required profile

• Bachelor's degree in Engineering or a related technical discipline.
• Minimum 3 years of experience in Quality, Manufacturing or Process Engineering in a regulated environment; medical device experience preferred.
• Experience with nonconformance management, CAPA, root cause analysis and investigations.
• Knowledge of Quality Management Systems; familiarity with ISO 13485 and ISO 14971 preferred.
• Lean Six Sigma Green Belt or equivalent is an asset.
• Willingness to travel domestically and internationally and to be based in Vršac or relocate.

Required skills

• SPC, process capability, Pareto and trend analysis.
• Microsoft Office and statistical software (Minitab preferred).
• Preferred: process validation, equipment qualification, extrusion, injection molding, automation or assembly.