Medical Device Software Quality Engineer

📋 Description

• The Medical Device Software Quality Engineer will report to the Quality and Regulatory Affairs Manager, contributing to software quality assurance for medical device product development.

• Responsible for ensuring software quality throughout the product development lifecycle.

• Oversee software lifecycle and AI model governance: Take ownership of QA oversight for testing activities by evaluating and approving strategies, plans, and reports for software and AI verification and validation, guaranteeing comprehensive coverage of safety-critical and AI-critical functions.

• Assist in validation activities for software and processes: Contribute to the preparation of IQ/OQ/PQ documentation, test protocols, and validation reports for IVD software and regulated tools utilized in US and Canadian GxP environments.

• Provide QA oversight throughout the entire software and AI model lifecycle, including requirements, design, implementation, V&V, release, and maintenance.

• Lead and manage end-to-end risk management for software and AI, including hazard identification, analysis, control, and ongoing review.

• Help compile and maintain the design history file (DHF) and technical documentation under the supervision of the manager.

• Support the management of nonconforming products: Document, track, and follow up on nonconformances.

• Assist in reviewing labeling and instructions for use (IFU): Ensure compliance of product labeling and user information with FDA and Health Canada requirements.

• Maintain and update Quality Management System (ISO 13485 / MDSAP) documents and records.

• Assist in preparing and executing internal audits: Gather audit evidence, coordinate schedules, document findings, and track the closure of audit actions under the guidance of the Manager.

• Coordinate and monitor QMS training: Maintain training records and competency matrices; schedule and confirm the delivery of QMS and role-specific training across the organization.

⛳️ Requirements

• A degree or equivalent in a relevant field (e.g., life sciences, engineering, quality management, regulatory affairs) or equivalent experience.

• At least 3 years of experience in a quality, regulatory, or related role within a medical device, IVD, pharmaceutical, or regulated software environment.

• Experience with digital pathology systems and AI-based digital pathology diagnostics is a significant advantage.

• Solid understanding of ISO 13485 QMS requirements or FDA 21 CFR Part 820; familiarity with UK, EU, MDSAP, or Health Canada medical device regulations is desirable.

• Good working knowledge of software as a medical device (SaMD) or IVD software concepts, including IEC 62304, is preferred.

• Experience with document control, CAPA, complaint handling, or audit support processes in a regulated setting is beneficial.

• Basic understanding of US FDA medical device regulatory pathways (510(k), De Novo) and Health Canada medical device license requirements; willingness to enhance knowledge of MDSAP and relevant US/Canadian regulations.

🏝️ Benefits

• Limited international travel to Europe as required.

• Regular collaboration with global teams across the U.S., Europe, and Canada.