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 & 820 Support quality activities across design, development and manufacturing Lead and contribute to risk management activities in line with ISO RM Plans, DFMEA, PFMEA, Risk Reports)Support design verification & validation strategies and documentation Coordinate supplier qualification and assessment Support internal and external audits Maintain design control and quality records in accordance with regulatory requirements Work cross-functionally to ensure an efficient regulatory submission and approval pathway Experience: Bachelor's degree in Science, Engineering or related discipline5+ years' QA experience within Class II medical devices Strong working knowledge of ISO 13485 and FDA QSRExperience across design control, risk management, CAPA, change control, audits and validation Proven ability to operate in a fast-paced, start-up or small company environment Excellent communication skills and strong attention to detail ISO 13485 Lead Auditor training desirable A 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.