Principle Quality Engineer
- You will Co-ordinate and drive the sterilisation, biocompatibility and environmental monitoring programs onsite, training quality inspectors on sterile release and driving increased approval and compliance.
- Drive and develop annual objectives and site compliance in relation to ISO11135, ISO10993, ISO14644, ISO11607, ISO13485, FDA QSR and DMR.
- Review and improve product and paperwork preparation for sterilisation and environmental monitoring in manufacturing.
- With customer and product quality in mind, analyse data and suggest potential improvements, developing set processes for the site.
- Oversee validation for sterilisation onsite.
- Lead FDA, NSAI, Customer and Corporate audits regarding sterilisation documentation and process.
- Ensure and manage continuous improvement and compliance projects, stemming from trend analysis or customer reports. This will mainly relate to sterilisation validation standards and biocompatibility standards.
- Will need good working knowledge of Sterilisation Cycle.
- Will work with the R&D team to ensure the customer specifications are met and all the testing is correct.
- Engineering or science degree, qualification in microbiology is preferable.
- Six sigma qualifications desirable.
- 1-3 years’ experience in a quality assurance and sterilization role.
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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