[Hiring] Medical Device Software Quality Engineer @Deciphex

Role Description

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:
• Own QA oversight of testing activities by reviewing and approving strategies, plans, and reports for software and AI verification and validation.
• Ensure adequate coverage of safety-critical and AI-critical functions, bias/robustness checks, and complete, audit-ready test documentation.
• 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).
• Ensure 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).
• Ensure 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.
• 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 under the direction of the Quality and Regulatory Affairs Manager.
• Support document and record control processes: issue, review, revise and retire controlled documents.
• Assist with CAPA and complaint handling: log, track and follow up on corrective actions, complaints and non-conformances.
• 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.
• Collect and compile quality metrics and KPI data; prepare regular quality dashboards and summary reports for the Manager.
• Support post-market surveillance (PMS) activities: collect and collate post-market data from complaint records, adverse event reports and product feedback.
• 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.
• Support preparation and maintenance of Health Canada medical device licence applications and MDSAP documentation.
• Assist in the preparation of global regulatory submissions to FDA, EU, UK and Health Canada.
• Support vigilance and post-market regulatory reporting for US and Canadian markets.

Qualifications

• 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.
• Basic familiarity with US FDA medical device regulatory pathways (510(k), De Novo) and Health Canada medical device licence requirements.
• Exceptional attention to detail in maintaining controlled documents, records and registers.
• Proficiency in tracking and reporting quality metrics (e.g. CAPA closure rates, complaint volumes, audit findings).
• 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.

Company Description

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.