Key Responsibilities
In this role, you will:
Support qualifications and control of ATE testers in V&V phase and production lines.
Support ECO/ECR processes, NPI projects, product updates, and cross-functional engineering changes.
Participate in supplier selection and conduct suppliers audits.
Work closely with R&D, engineering, manufacturing, and operations teams to enhance product quality and resolve technical issues.
Drive continuous improvement initiatives using tools such as Six Sigma, Lean, and Root Cause Analysis (RCA).
Support RMA/DOA processes and continuous reduction of field failures.
Ensure compliance with ISO 13485, FDA 21 CFR 820, MDR, and other applicable medical device regulations.
Maintain and support quality documentation, including CAPA, Non-Conformance Reports (NCRs), and risk management documentation.
Bachelors degree in Engineering (Mechanical, Electrical, Biomedical, or related field).
3+ years of experience in Quality, medical device experience is a strong advantage.
Strong analytical and problem-solving skills, including hands-on experience with RCA tools (5-Why, Fishbone, etc.).
Familiarity with ATE systems, production testing, and/or field reliability analysis – a strong advantage.
Working knowledge of ISO 13485, FDA 21 CFR 820, and ISO 14971 risk management.
Excellent communication and collaboration skills, with the ability to work effectively across functions.
A proactive, structured, and detail-oriented working style.
Fluent in English.
