The Senior Quality Engineer provides a support role to the Quality Manager in the routine maintenance of the Quality Management Systems and in Quality related projects. The Senior Quality Engineer reports to the QA & RA Manager.
- Possesses and applies comprehensive knowledge of Quality, and its application within the organisation, to the completion of complex assignments.
- Advanced knowledge of the organisation’s operations and practices to enable informed decisions and providing direction to Quality team and other functional areas.
- Responsibility for delivery of projects originated in QA or participate within Core Team for Quality deliverables of business wide projects.
- Identifies key barriers/core problems and applies problem-solving skills in order to deal creatively with complex situations. Troubleshoots and resolves complex problems with effective solutions.
- Makes decisions under conditions of uncertainty, sometimes with incomplete information, that produce effective end results. Applies risk assessment techniques in such circumstances.
- Independently performs assignments with instruction limited to results expected. Determines and develops approach to solutions.
- Drives business improvements through mentoring and support for the continuous improvement initiatives.
- Escalation point for quality related non-conformances and CAPAs.
- Drives compliance cross functionally in alignment with the regional objective for collaboration and multi-site ISO13485 certification.
- Third level qualification.
- Minimum 5 years of experience in medical device industry with minimum 3 year of progressively responsible positions, including;
- competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP),
- awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL)
- Broad knowledge of engineering and technical applications applied in development of medical devices useful.
For a confidential discussion and more information on the role, please contact Stephen Kelly on 091-706714.