Senior Quality Systems Engineer – Start-up
- Manage complaints and the complaint handling system, ensuring that they are dealt with in a proper and timely manner
- Oversee the CAPA system, CAPAs in full and ensure investigations are carried out in line with notified body requirements
- Manage the audit schedule both internally and externally
- Assist in supplier management, selection, approval, monitoring and reporting
- Take ownership of the document control for the site
- Monitor MDR requirements for QMS
- Lead activities for the QMS and ensure certification to ISO, FDA, PMDA regulations
- Manage the software validation process
- Must have at least a diploma in Engineering, Science, QA or similar discipline.
- Should have 5 years or more experience with a working knowledge of ISO13485, 21CFR 820, MDD/MDR and Risk Management.
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: firstname.lastname@example.org
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