Our client a leading medical device manufacturing company based in the West of Ireland requires an experience Quality Team Lead for a permanent role in Mayo. This job is permanent job. This job included the necessary monitoring, feedback and corrective action mechanisms to ensured continued compliance to both system provisions as well as product (device) requirements.
Key responsibilities of the Associate Quality Manager Job:
- Lead and develop the team
- Develop and advise on the continued development of quality systems and procedures, including the development of product specifications / drawings / quality plans in conjunction with NPC personnel and the development of Master Validation Plans as required.
- Provide leadership in change management and risk assessment, specifically process risk and capability analyses
- Conduct, lead, or direct product complaint investigations.
- Coordinate the Corrective and Preventive Action (CAPA) program
- Participate in the Internal audit program
- Provide project leadership for implementing continuous improvement projects
- Provide leadership and resources for verification and release of finished goods into distribution
- Ensure the quality team is trained to FDA QSR and ISO 13485 / 14971 requirements
- 8 years' experience in a quality engineering/systems role including 2 years people management experience
- Problem Solving and Analysing
- Project Managing (includes AFE process)
- Fiscal Managing (includes budget preparation)
- Goal Setting and effective communicating/leading of the team
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