Location:
- Ireland/UK based role working from home.
- 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 sections, format submissions, and maintain submission 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; maintain reporting records per FDA 21 CFR Part 803 and Health Canada Medical Device Regulations.
About You (Skills and Experience):
- Degree or equivalent in a relevant discipline (e.g. life sciences, engineering, quality management, regulatory affairs) or equivalent experience.
- Training or coursework in ISO 13485 or quality management systems is desirable.
- Regulatory affairs training (e.g. RAC coursework) or internal audit training is an advantage.
- 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.
- Exposure to FDA regulatory databases (e.g. FURLS, GUDID) or Health Canada device licensing portal is desirable; willingness to learn these systems is essential.
- Experience with eQMS or quality management software tools is an advantage.
- Experience with GCP requirements and clinical evaluations for SaMD is an advantage.
- Working knowledge of or willingness to develop proficiency in ISO 13485:2016 and FDA 21 CFR Part 820; ability to apply 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 medical device 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); ability to build and maintain dashboards or summary reports using spreadsheet tools or quality software.
- Ability to manage multiple tasks, track deadlines and maintain accurate records simultaneously 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.
Deciphex is an equal opportunities employer and we are committed to the principle of equality. All qualified applicants will be considered for employment without regard to age, race, religious beliefs, political views, gender identity, affectional or sexual orientation, national origin, family or marital status (including pregnancy), disability, membership of the traveling community or any other classification protected by applicable law.
