Medical Device Software Quality Engineer
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Job Description
Medical Device Software Quality Engineer overseeing software quality for product development. Responsible for QA activities, regulatory compliance, and risk management in a remote capacity.
Responsibilities:
- The Medical Device Software Quality Engineer reports to the Quality and Regulatory Affairs Manager, supporting software quality for medical device product development
- Software Quality for product development
- Software lifecycle & AI model governance: Software Testing oversight: Own QA oversight of testing activities by reviewing and approving strategies, plans, and reports for software and AI verification and validation, ensuring adequate coverage of safety‑critical and AI‑critical functions
- Support validation activities for software and processes: assist in the preparation of IQ/OQ/PQ documentation, test protocols and validation reports for IVD software and regulated tools used in US and Canadian GxP environments
- Provide QA oversight across the full software and AI model lifecycle (requirements, design, implementation, V&V, release, maintenance)
- Risk management: Lead and maintain end‑to‑end risk management for software and AI (hazard identification, analysis, control, and ongoing review)
- Assist with compilation and maintenance of the design history file (DHF) and technical documentation under manager oversight
- Support control of nonconforming products: document, track and follow up on nonconformances
- Support labelling and instructions for use (IFU) review: check compliance of product labelling and user information with FDA and Health Canada requirements
- Quality Management System (ISO 13485 / MDSAP) Maintain and update QMS documents and records
- Support preparation and execution of internal audits: compile audit evidence, coordinate schedules, record findings, and track closure of audit actions under the direction of the Manager
- Coordinate and track QMS training: maintain training records and competency matrices; schedule and confirm delivery of QMS and role-specific training across the organisation
Requirements:
- Degree or equivalent in a relevant discipline (e.g. life sciences, engineering, quality management, regulatory affairs) or equivalent experience
- Minimum 3 years of experience in a quality, regulatory, or related role in a medical device, IVD, pharmaceutical, or regulated software environment
- Experience with digital pathology systems and AI based digital pathology diagnostics is a distinct advantage
- Good working knowledge with ISO 13485 QMS requirements or FDA 21 CFR Part 820; exposure to UK, EU, MDSAP or Health Canada medical device regulations is desirable
- Good working knowledge with software as a medical device (SaMD) or IVD software concepts including IEC 62304, is desirable
- Experience with document control, CAPA, complaint handling, or audit support processes in a regulated environment is an advantage
- Basic familiarity with US FDA medical device regulatory pathways (510(k), De Novo) and Health Canada medical device licence requirements; willingness to develop working knowledge of MDSAP and applicable US/Canadian regulations
Benefits:
- Limited international travel to Europe as required
- Regular collaboration with global teams across the U.S., Europe, and Canada
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