A clinical-stage medical device organisation is recruiting a Senior Quality Engineer to join their team. This is a chance to join a company that is developing novel innovative, minimally invasive technologies.This is a fantastic opportunity for an experienced Senior Quality Assurance Engineer to play a key role in building and maintaining a best-in-class Quality Management System, while working closely with R&D, Manufacturing and Regulatory teams across the full product lifecycle — from early concept through to regulatory approval and global patient treatment.Responsibilities:Develop, implement and continuously improve a compliant QMS aligned with ISO 13485 and 21 CFR Parts 808, 812 & 820Support quality activities across design, development and manufacturingLead and contribute to risk management activities in line with ISO RM Plans, DFMEA, PFMEA, Risk Reports)Support design verification & validation strategies and documentationCoordinate supplier qualification and assessmentSupport internal and external auditsMaintain design control and quality records in accordance with regulatory requirementsWork cross-functionally to ensure an efficient regulatory submission and approval pathwayExperience:Bachelor's degree in Science, Engineering or related discipline5+ years' QA experience within Class II medical devicesStrong working knowledge of ISO 13485 and FDA QSRExperience across design control, risk management, CAPA, change control, audits and validationProven ability to operate in a fast-paced, start-up or small company environmentExcellent communication skills and strong attention to detailISO 13485 Lead Auditor training desirableA super opportunity to be part of a company who are developing life changing medical technologies. Please send an up to date CV to be considered.