Our client is a world-leading medical device company based in the Dublin West, Ireland.
Do you want to join an organisation which is one of the world's leading health care suppliers and is in the Top 20 ranking of Medical Devices Companies? Our client is also a company that is recognised as a Great Place To Work in Ireland and one that has a mission to become the most progressive company in the life sciences industry.
This role will have the following responsibilities;
- Defining and periodically updating Quality Procedures in conjunction with operating staff, while ensuring compliance with ISO 13485 and GDP
- Restructuring the Document Management System in compliance with the Corporate Integrated Management System
- Conducting quality audits against the ISO 13485 standard and Good Distribution Practice. Preparing audit reports, assessing and verifying planned corrective and preventive actions and reviewing the effectiveness of the corrective and preventive actions taken
- Ensuring the Quality Management system (QMS) is understood by providing training to company personnel regarding updated documents
- Recording, investigating and reporting incidents and deviations to the Responsible Person
- Assisting Risk Owners and Process Owners in assessing risks and assigning counteractive measures
- Conducting Supplier Audits and Assessments, as required
- Documenting and managing change controls through to completion
The ideal person will have;
- Primary Degree in a relevant discipline
- Minimum of 2 years' post qualification experience working in a Quality Assurance Role in the Medical Device/Pharmaceutical Industry to include experience with QMS, GDP and ISO 13485.
To learn more about this role apply online or call Helena Boyle on + 353 1 6321870/ + 353 87 3360953 for a confidential discussion.