Global SaMD Quality Engineer – Medical Device Software

Deciphex; Ireland; On-site; EUR 70,000 - 95,000; Full time

Job summary

Deciphex is seeking a Medical Device Software Quality Engineer based in Ireland to support software quality for medical device product development, ISO 13485:2016 and MDSAP, and regulatory activities for US and Canada.

You will oversee QA testing, validation, risk management for software and AI, maintain DHF, CAPA, and liaise with cross‑functional teams to ensure compliant, safe medical software products.

Qualifications

• Minimum 3 years' experience in quality/regulatory role in a medical device or regulated software environment.
• Experience with ISO 13485 QMS and FDA 21 CFR Part 820 is desirable.
• Familiarity with SaMD / IVD software concepts (IEC 62304) is advantageous.
• Ability to manage documentation control, CAPA, complaint handling, and audits.
• Willingness to learn US/Canadian regulatory requirements and systems such as FURLS and GUDID.

Responsibilities

• Oversee QA testing strategies, plans, and reports for software and AI verification/validation.
• Support IQ/OQ/PQ documentation and validation reports for regulated software.
• Govern software/AI lifecycle from requirements to release with risk-based change control.
• Lead end-to-end risk management for software/AI and maintain risk files.
• Assist DHF and technical documentation with traceability per ISO 13485 and FDA 21 CFR 820.
• Coordinate CAPA, complaint handling, nonconformances, and link to risk records.
• Support QMS document control, internal audits, and training records.

Skills

Quality assurance

Regulatory awareness

AI/ML validation

Software testing leadership

Documentation control

Education

Life sciences / Engineering degree

ISO 13485 training

Regulatory affairs training (RAC)

Tools

FURLS/GUDID

eQMS software

CAPA system

Job description

Deciphex is seeking a Medical Device Software Quality Engineer based in Ireland to support software quality for medical device product development, ISO 13485:2016 and MDSAP, and regulatory activities for US and Canada.

You will oversee QA testing, validation, risk management for software and AI, maintain DHF, CAPA, and liaise with cross‑functional teams to ensure compliant, safe medical software products.