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QMS Design Lead - Healthcare Software

£60,000 - 90,000
High Holborn 326-330, London
£60,000 - 90,000
Company Size icon
Company Size
5k+
Company Type icon
Company Type
Services
Exp Level icon
Exp Level
Lead
Job Type icon
Job Type
Full-Time
Language icon
Language
English
Visa sponsorship icon
Visa sponsorship
No

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.

Technologies

AI

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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