QMS, SaMD, ISO 13485, IEC 62304, ISO14971, Medtech, Digital Healthcare, Software Development Lifecycle, Agile, Dev OpsMy consultancy client is looking for a

QMS lead

with

deep SaMD expertise

to shape the future of digital healthcare services. You will lead the design, implementation, and continuous improvement of our ISO 13485-aligned QMS for our a cutting-edge software which will be classified as

Software as a Medical Device (SaMD) .The key areas of expertise are toOwn 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 velocityStrong 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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