Production and supplier Quality Engineer

About this opportunity

We are seeking a highly motivated and experienced Production and Suppliers Quality Engineer to drive exceptional product quality, patient safety, and field reliability across the Installed Base (IB). This is a key technical role supporting production stability, RMA/DOA investigations, Automated Test Equipment (ATE) performance, and cross-functional quality engineering initiatives in a regulated medical device environment.

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.

• Bachelor’s 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.