Production and supplier Quality Engineer

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.

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.