SaMD Quality Engineer - AI & Regulatory Compliance

Deciphex

Ireland

On-site

EUR 70,000 - 90,000

Full time

13 days ago

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Job summary

Deciphex is seeking a Medical Device Software Quality Engineer to support software quality for medical device product development and QMS operations under ISO 13485:2016 and MDSAP, focusing on AI-assisted diagnostic tools for US/Canadian markets. You will report to the Quality and Regulatory Affairs Manager and help maintain FDA/Health Canada compliance.

You will lead QA oversight of testing strategies, assist IQ/OQ/PQ activities, and manage risk across the software/AI lifecycle, including DHF

Qualifications

3+ years in quality, regulatory, or related role in medical devices or regulated software.
Experience with SaMD or IVD software concepts (IEC 62304) is desirable.
Knowledge of ISO 13485 and FDA 21 CFR Part 820 is desirable.

Responsibilities

Oversee software testing oversight: approve testing strategies, plans and reports for software and AI verification and validation.
Assist IQ/OQ/PQ documentation, test protocols and validation reports for IVD software in US/Canada GxP environments.
Provide QA oversight across the software/AI lifecycle including risk management and change control.
Lead end-to-end risk management for software and AI; maintain risk files with results and CAPA outputs.
Assist with DHF/technical documentation and traceability records under manager oversight.
Support nonconforming product controls, and link complaints/incidents to risk management records.
Review labelling/IFU for FDA/Health Canada compliance; maintain labelling records.