Quality Control Engineer - X-Ray Systems

About the role

XERA Medical Systems and Technology designs and manufactures X-ray systems used worldwide for accurate diagnosis. As Quality Control Engineer, you will own the final inspection process: define what is tested and why, make the final pass/fail decision and guide the Quality Control Technicians who carry out the day-to-day inspections. The position is full-time and on-site.

Key responsibilities

• Own the final inspection of completed X-ray systems and make the final pass/fail decision before shipment.
• Identify and propose the most relevant test items based on the product's electrical, mechanical and radiological characteristics, prioritising higher-risk areas.
• Develop sampling inspection strategies aligned with AQL standards and write and improve inspection specifications and procedures in line with ISO 13485.
• Review and approve inspection records and the Device History Record to ensure product traceability.
• Lead root cause analysis and corrective and preventive actions (CAPA) when nonconformities occur, and feed findings back into production and design.
• Manage the calibration programme for precision measuring instruments and evaluate measurement uncertainty.
• Train, guide and review the work of Quality Control Technicians.

Required profile

• Bachelor's degree in Electrical-Electronics, Biomedical, Mechatronics or a related engineering discipline, with 2-4 years of relevant experience.
• Able to read circuit diagrams and technical specifications independently.
• Working knowledge of precision measurement equipment and measurement uncertainty.
• Data-driven quality mindset, able to analyse nonconformity trends.
• Strong communication skills with Production and R&D, and strong interpersonal skills.
• Turkish and English sufficient for daily work and technical documents.

Required skills

• Electronic engineering and electronic circuits
• ISO 13485 and QMS
• Quality inspection and test method design
• Radiation safety (preferred)

Preferred qualifications include radiation-related experience, ISO 13485 or medical device quality management experience, radiation safety certification, ISO 13485 internal auditor training and statistical quality tools such as SPC and sampling plans. The career path leads to Senior Quality Control Engineer and then QA Engineer.