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Senior Quality Systems Specialist, Galway
Client: Life Science Recruitment
Location: Galway, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: 3c414de1e16d
Job Views: 116
Posted: 21.01.2025
Expiry Date: 07.03.2025
Job Description:
We’re currently recruiting for an exciting opportunity with a Medical Device organization based in Galway. 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:
* Work with Key Stakeholders to lean the current QMS to achieve an efficient QMS
* Work closely with the notified body to successfully obtain ISO13485 certification
* Ensure that the necessary updates are communicated to the competent authority, regulatory bodies and customers as changes arise
* Work with Regulatory Affairs to provide documentation to external customers to support their submissions
* Support Notified Body / Regulatory Agency / Customer Audits
* Perform Internal and Supplier Audits
* Manage the tracking of the Corrective / Preventive Management Process, working closely to support CAPA leads to successfully implement effective CAPA
* Manage the tracking of the Non-Conformance Process, working closely with NCR action owners to ensure timely closure of Non-conformances
Education & Experience:
* Minimum of level 8 degree in related field
* Experience in medical device or other highly regulated industry
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [emailprotected] for further information.
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