We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

- Support new product design and development, design transfer, design validation, design review, risk management, etc. working closely with Device Engineering through the entire product life cycle.
- Design control compliance ensuring consistent, workable and compliant planning, development (inputs, outputs and review), testing (verification, validation and review), and change management;
- Regulatory compliance: ensuring product development and maintenance in accordance with FDA QSR's (21 CFR Part 820), ISO 13485, EU MDR, CMDR, MDD, MDSAP, J-PAL and relevant guidance documents
- Design risk management, assuring appropriate and consistent risk management tool use i.e. FMEA, FTA, etc. for all programs and projects, compliant with regulatory standards (ISO/EN 14971) and industry practices,
- Supplier qualification, vendor management and performance evaluation
- Administrator of the Change Control Board (CCB).
- Monitor and ensure the timely closure of CAPA, Management of Change (MOC) records, internal audit, and regulatory findings.
- Track and trend quality system metrics
- Support preparation for management reviews, internal audits, and external agency audits.
- Other tasks deemed necessary by the Quality Manager

Education & Experience

- Bachelor degree in science, microbiology, engineering or equivalent technical field with 5+ years of cGMP experience
- Experience in medical device design control and product realization


If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.