Overview

QMS, SaMD, ISO 13485, IEC 62304, ISO14971, Medtech, Digital Healthcare, Software Development Lifecycle, Agile, Dev OpsResponsibilities

Own the

QMS vision and strategy

for the SaMD programme.Ensure full alignment with

ISO 13485 ,

IEC 62304 , and

ISO 14971

standards.Embed QMS principles into

agile product squads

without compromising delivery velocity -Strong understanding of software development life cycles (Agile, DevOps) in regulated environments.Prepare the organisation for

external audits and ISO accreditation .Champion a culture of

continuous improvement and quality-first thinkingIf this sounds of interest please send me your cv ASAP for review

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