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High Holborn 326-330, London
£60,000 - 90,000
Requirements
Must:
- Deep expertise in ISO 13485, particularly in healthcare software.
- Proven track record in QMS design through to accreditation.
- Strong understanding of Agile and DevOps practices in regulated environments.
- Excellent communication skills with top-tier documentation capabilities.
- Experience in pharmaceutical or MedTech platforms.
- Familiarity with ISO 14971 and IEC 62304 standards.
- Exposure to AI-enabled QMS tooling.
Responsibilities
- Own the quality management system (QMS) strategy for Software as a Medical Device (SaMD).
- Lead the ISO 13485 gap analysis and implement the rollout plan.
- Integrate the QMS into agile workflows across product squads.
- Deliver training initiatives and drive adoption among technology teams.
- Liaise effectively with auditors and regulatory bodies.
- Champion a culture of continuous improvement and quality within the organization.
Description
Our leading company is seeking a strategic QMS Lead to develop and implement an ISO 13485-aligned Quality Management System for a cutting-edge healthcare platform. You will play a critical role in driving compliance, shaping governance, and preparing the business for audits and accreditation, all while collaborating closely with agile product teams. This role is outside IR35 and offers the opportunity to work UK-wide. We are looking for someone who can start immediately and is passionate about quality management in healthcare.
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Which companies are hiring for Machine Learning Engineer jobs in the UK?
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The company with most openings is Ocho as they are hiring for 61 different Machine Learning Engineer jobs in the UK. They are probably quite committed to find good Machine Learning Engineers.
The company with most openings is Ocho as they are hiring for 61 different Machine Learning Engineer jobs in the UK. They are probably quite committed to find good Machine Learning Engineers.