Medical Device Software Quality Engineer

Stack

Responsibilities

• ▹Own QA oversight of software and AI verification and validation testing: strategies, plans and reports
• ▹Support validation activities: IQ/OQ/PQ documentation, test protocols and validation reports for IVD software
• ▹Provide QA oversight across the full software and AI model lifecycle: requirements, design, implementation, V&V, release, maintenance
• ▹Lead and maintain end-to-end risk management for software and AI
• ▹Assist with the design history file and technical documentation under ISO 13485 and FDA 21 CFR 820
• ▹Support control of nonconforming products and linkage between complaints, incidents and risk records
• ▹Support labelling and instructions for use compliance review
• ▹Maintain and update QMS documents and records under ISO 13485 and MDSAP
• ▹Assist with CAPA and complaint handling, root cause analysis
• ▹Support preparation and execution of internal audits
• ▹Coordinate and track QMS training records and competency matrices