Medical Device Software Quality Engineer

Stack

Responsibilities

• ▹Review and approve 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 audit-ready test documentation
• ▹Support validation of software and processes: prepare 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), governing datasets, training/validation, versioning, and risk-based change control that maintains approved clinical performance
• ▹Lead and maintain end-to-end risk management for software and AI (hazard identification, analysis, control, ongoing review), mitigating AI-specific risks and updating risk files with 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, in line with ISO 13485 and FDA 21 CFR 820
• ▹Support control of nonconforming products: document, track, and follow up on nonconformances, and link complaints, incidents, and risk management records
• ▹Support labelling and instructions for use (IFU) review: check compliance with FDA and Health Canada requirements and maintain labelling records
• ▹Maintain and update QMS documents and records in compliance with ISO 13485:2016 and MDSAP requirements
• ▹Support document and record control: issue, review, revise, and retire controlled documents, and maintain registers and version control
• ▹Assist with CAPA and complaint handling: log, track, and follow up on corrective actions, complaints, and non-conformances, and support root cause analysis
• ▹Support preparation and execution of internal audits: compile audit evidence, coordinate schedules, record findings, and track closure of audit actions
• ▹Coordinate and track QMS training: maintain training records and competency matrices, and schedule and confirm delivery of training
• ▹Collect and compile quality metrics and KPI data (e.g., CAPA status, complaint trends, audit findings) and prepare regular quality dashboards and summary reports for the Manager and management review
• ▹Support post-market surveillance (PMS): collect post-market data from complaint records, adverse event reports, and product feedback, and assist in preparing PMS reports for US and Canadian markets
• ▹Support the supplier control process: maintain the approved supplier list and assist with supplier questionnaires, quality agreement records, and incoming inspection documentation
• ▹Support Regulatory Affairs with updates to FDA establishment registration and device listing records (FURLS/GUDID) and flag renewal deadlines to the Manager
• ▹Prepare and maintain Health Canada medical device licence applications and MDSAP documentation, and track licence renewal timelines and correspondence
• ▹Assist in the preparation of global regulatory submissions to FDA, EU, UK, and Health Canada (e.g., 510(k) support packages, De Novo requests, licence applications): compile documentation sections, format submissions, and maintain trackers and correspondence records
• ▹Support vigilance and post-market regulatory reporting for US and Canadian markets: track timelines for adverse event and MDR reporting (FDA 5/30-day, Health Canada), prepare draft reports for Manager review, and maintain records per FDA 21 CFR Part 803 and Health Canada Medical Device Regulations

Requirements

• ▹Degree or equivalent experience in a relevant discipline (e.g., life sciences, engineering, quality management, regulatory affairs)
• ▹Minimum 3 years of experience in a quality, regulatory, or related role in a medical device, IVD, pharmaceutical, or regulated software environment
• ▹Good working knowledge of ISO 13485 QMS requirements or FDA 21 CFR Part 820, or willingness to develop it, and the ability to apply the requirements to day-to-day quality operations in a software/IVD environment
• ▹Basic familiarity with US FDA medical device regulatory pathways (510(k), De Novo) and Health Canada licence requirements; willingness to develop working knowledge of MDSAP and applicable US/Canadian regulations
• ▹Exceptional attention to detail in maintaining controlled documents, records, and registers; proficiency in managing version-controlled documentation in an eQMS or equivalent system
• ▹Proficiency in tracking and reporting quality metrics (e.g., CAPA closure rates, complaint volumes, audit findings) and building dashboards or summary reports using spreadsheet tools or quality software
• ▹Ability to manage multiple tasks, track deadlines, and maintain accurate records across QMS and regulatory activities
• ▹Ability to communicate clearly with cross-functional teams, suppliers, and the Quality and Regulatory Affairs Manager in a remote or hybrid environment
• ▹Demonstrated willingness to develop technical knowledge and take on increasing responsibility within the quality and regulatory function under the guidance of the Manager
• ▹Exposure to FDA regulatory databases (e.g., FURLS, GUDID) or the Health Canada device licensing portal is desirable; willingness to learn these systems is essential
• ▹Right to work in the US (per the posting, candidates must be based in and have the right to work in the US); the company cannot offer visa sponsorship

Nice to have

• ▹Training or coursework in ISO 13485 or quality management systems
• ▹Regulatory affairs training (e.g., RAC coursework) or internal audit training
• ▹Experience with digital pathology systems and AI-based digital pathology diagnostics (a distinct advantage)
• ▹Exposure to UK, EU, MDSAP, or Health Canada medical device regulations
• ▹Working knowledge of software as a medical device (SaMD) or IVD software concepts, including IEC 62304
• ▹Experience with document control, CAPA, complaint handling, or audit support processes in a regulated environment
• ▹Experience with eQMS or quality management software tools
• ▹Experience with GCP requirements and clinical evaluations for SaMD

Soft skills

What we offer

• ▹Work from home (Ireland/UK)
• ▹Regular collaboration with global teams across the U.S., Europe, and Canada

About the company

Deciphex develops digital pathology and AI-based diagnostic software, built to ISO 13485 and MDSAP requirements, primarily for the US and Canadian markets. It is an equal opportunities employer.