Senior Quality Engineer
Mason Alexander New ·www.masonalexander.ie
Apply directA 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 14971 (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
Requirements:
- 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.