Associate Quality Engineer – Developed Start-up
- Oversee all incoming, in process and final inspection and validation for manufacturing.
- Issue batch documentation for manufacturing and production.
- Generate NCRs and CAPAs for defects, deviations and non-conformities on-site and on clinical sites too, ensuring effective closure.
- Support calibration and maintenance programs onsite.
- Work cross functionally across all departments, supporting the development of relevant training programs and continuous improvement programs.
- Maintain Design History Files, manage change requests and support regulatory compliance and the submission process.
- Help drive changes in procedures and processes in relation to ISO13485 and CE Registration.
- Degree or Post-Grad qualification in quality Management or engineering with 3 years or more experience in a medical device manufacturing environment.
- Must have exposure to FDA/ISO13485/CE Registration.
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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