Cure Talent are delighted to be partnered with a specialist medical device manufacturer whose portable neonatal incubators are deployed in some of the world''s most challenging environments, from emergency responses in active conflict zones to hospitals across multiple international markets including the US and Australia. It is a business with a clear social purpose and serious commercial momentum, having grown sales by more than 10x year-on-year. FDA-cleared and scaling fast, the team is small, pragmatic, and genuinely committed to the work they do. This is not a corporate quality role. The OpportunityAs Quality Assurance Manager, you will take full ownership of the ISO 13485 QMS and lead quality activity across the business. Working closely with the leadership team and based in Stevenage, Hertfordshire with two days per week working from home, you will be expected to hit the ground running across a broad remit that includes: Maintaining, developing and continuously improving the QMS in line with ISO 13485:2016 and applicable medical device regulationsLeading non-conformity management, CAPA, change control, document control and training processesPlanning and conducting internal, supplier and Notified Body auditsManaging supplier qualification, monitoring and performance reviewsSupporting batch release, traceability, complaint handling and post-market surveillance activitiesContributing to CE marking maintenance under the MDR, Clinical Evaluation Reports, PSURs and wider ..... full job details .....