Quality Engineer

We are seeking a Quality Engineer with experience in medical device design quality and risk management to support product development from concept through commercialization. This role will primarily support R&D and Process Engineering activities to ensure compliance with design controls and risk management requirements.

The ideal candidate must have hands-on experience with design controls and risk management, including FMEA and structured problem‑solving methodologies, and a solid understanding of ISO 13485, 21 CFR 820, and ISO 14971 requirements to identify and mitigate potential compliance, product and patient safety risks.

Objective:

The objective of this position is to provide the level of resource necessary to maintain, monitor and improve the Quality Management System (QMS) for Ambu USNV, to ensure compliance with regulatory requirements and established local and Corporate practices.

Responsibilities and Essential Functions (Applicable to...