Remote SaMD Quality Engineer for AI & ISO 13485

Deciphex Limited; Ireland; Remote; USD 74,000 - 102,000; Full time

Job summary

Deciphex Limited in Ireland 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, primarily for US and Canadian markets.

You will oversee software testing, V&V, risk management, CAPA, document control, and regulatory submission support under the guidance of the Quality and Regulatory Affairs Manager; experience with SaMD and AI-enabled tools is advantageous.

Qualifications

• 3+ years in quality/regulatory roles in medical devices or regulated software
• Experience with ISO 13485 QMS and FDA 21 CFR Part 820 desirable
• Familiarity with AI-enabled diagnostic tools is an advantage

Responsibilities

• QA oversight of software testing for AI/medical device validation
• Support IQ/OQ/PQ and validation documentation for regulated software
• Maintain risk management and CAPA processes for software/AI
• Assist with DHF and regulatory documentation under manager guidance
• Coordinate with Regulatory Affairs on submissions and reporting

Skills

ISO 13485

MDSAP

SaMD knowledge

Regulatory affairs

QMS documentation

AI model governance

GxP environments

Education

Degree in life sciences or engineering

Regulatory affairs training desirable

Tools

eQMS

FURLS

GUDID

IEC 62304

Job description

Deciphex Limited in Ireland 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, primarily for US and Canadian markets.

You will oversee software testing, V&V, risk management, CAPA, document control, and regulatory submission support under the guidance of the Quality and Regulatory Affairs Manager; experience with SaMD and AI-enabled tools is advantageous.