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 discipline
* 5+ years' QA experience within Class II medical devices
* Strong working knowledge of ISO 13485 and FDA QSR
* Experience 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.