Medical Device Software Quality Engineer

Deciphex

Medical Device Software Quality Engineer involved in supporting software quality and regulatory compliance for medical products. Collaborating on global teams to develop documentation and risk management.

Posted 7/28/2026full-timeRemote • 🇮🇪 IrelandMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in software quality assurance for medical devices, including risk management, regulatory compliance, and documentation processes. Proficient in ISO 13485 and FDA regulations, with a strong understanding of IVD software and SaMD concepts.

Highest-signal resume keywords

ISO 13485 QMS RequirementsFDA 21 CFR Part 820Software As A Medical Device (SaMD)Risk ManagementDocument Control

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ManagementRegulatory AffairsValidation ReportsTest ProtocolsCAPAComplaint HandlingAudit SupportIQ/OQ/PQ DocumentationIEC 62304MDSAP Documentation

Industry Keywords

Medical DeviceIVDPharmaceuticalGxP EnvironmentsHealth Canada RegulationsUS FDA Regulatory Pathways510(k)De NovoUK RegulationsEU Regulations

About the role

Key responsibilities & impact

The Medical Device Software Quality Engineer reports to the Quality and Regulatory Affairs Manager.
Supporting software quality for medical device product development.
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.
Lead and maintain end‑to‑end risk management for software and AI.
Support control of nonconforming products: document, track and follow up on nonconformances.
Support preparation and maintenance of Health Canada medical device licence applications and MDSAP documentation.

Requirements

What you’ll need

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.
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 of 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

Comp & perks

Health insurance
Professional development
Flexible working arrangements