Location:
- U.S. based role working from home. Preferably based on the East Coast, United States.
- Limited international travel to Europe as required
- Regular collaboration with global teams across the U.S., Europe, and Canada
Right to Work:
- Candidates must be based in and have the right to work in US.
- We are unable to offer US visa sponsorship for this US based role.
About this Role:
The Medical Device Software Quality Engineer
reports to the Quality and Regulatory Affairs Manager, supporting software quality for medical device product development, day-to-day Quality Management System (QMS) operations to ISO 13485:2016 and MDSAP requirements, and assisting with regulatory compliance activities for medical software (including AI-assisted diagnostic tools) primarily in the US and Canadian markets.
Responsibilities:
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, bias/robustness checks, and complete, audit-ready test documentation.
- 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), ensuring robust governance of datasets, training/validation, versioning, and risk‑based change control that maintains approved clinical performance.
Risk management:
- Lead and maintain end‑to‑end risk management for software and AI (hazard identification, analysis, control, and ongoing review), ensuring AI‑specific risks are mitigated and risk files are continuously updated using test results, post‑market data, and CAPA outputs.
- Assist with compilation and maintenance of the design history file (DHF) and technical documentation under manager oversight, including traceability records, design inputs/outputs, and review records in line with ISO 13485 and FDA 21 CFR 820.
- Support control of nonconforming products: document, track and follow up on nonconformances; assist with linkage between complaints, incidents, and risk management records.
- Support labelling and instructions for use (IFU) review: check compliance of product labelling and user information with FDA and Health Canada requirements; maintain labelling records and track review status.
Quality Management System (ISO 13485 / MDSAP)
- Maintain and update QMS documents and records under the direction of the Quality and Regulatory Affairs Manager, ensuring compliance with ISO 13485:2016 and MDSAP requirements.
- Support document and record control processes: issue, review, revise and retire controlled documents; maintain registers and ensure version control per procedure.
- Assist with CAPA and complaint handling: log, track and follow up on corrective actions, complaints and non-conformances; prepare records and support root cause analysis activities under manager guidance.
- 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.
- Collect and compile quality metrics and KPI data (e.g. CAPA status, complaint trends, audit findings); prepare regular quality dashboards and summary reports for the Manager and management review inputs.
- Support post-market surveillance (PMS) activities: collect and collate post-market data from complaint records, adverse event reports and product feedback; assist in the preparation of PMS reports for US and Canadian markets.
Supplier and process control
- Support the supplier control process: maintain the approved supplier list; assist with supplier questionnaires, quality agreement records and incoming inspection/acceptance documentation under manager direction.
Regulatory Affairs Support
- Support Regulatory Affairs with maintenance update to FDA establishment registration and device listing records in FURLS/GUDID; ensure listing information is current and accurate, and flag renewal deadlines to the Manager.
- Support preparation and maintenance of Health Canada medical device licence applications and MDSAP documentation; assist with tracking licence renewal timelines and correspondence with Health Canada.
- Assist in the preparation of global regulatory submissions to FDA, EU, UK and Health Canada (e.g. 510(k) support packages, De Novo requests, medical device licence applications): compile documentation se