What you need to know
You will work as a Senior Quality Engineer for our client based in the Waterford City within their Quality Department.
This is a 12-month contract with possibility of extension.
Your new job
Key duties & responsibilities:
- Providing support to ensure R&D projects and New Product Set Ups.
- Ensure that the Quality management system is adhered to.
- Lead failure analysis PFMEA.
- Provide validation support by approval of validation documentation.
- Lead CAPA/Nonconformance activity.
- Ensure transfer of Quality knowledge to manufacturing quality engineers and coordinate the training of quality engineers/technicians on new quality systems and equipment and products. Ensure all appropriate documentation is in place prior to production start.
What are we looking for?
- Third level Qualifications in Science or Engineering
- Minimum 3-5 years’ experience in a regulated pharmaceutical/medical device with at least 2 years in a senior Quality Role essential.
- Experience in providing Quality Support for Product Development and validation.
- Understanding and experience of the requirements of ISO 13485, 21 CFR Part 820 and Part 11.
- Must have good computer skills (Microsoft Office Products word processing, spreadsheets, data base.
Apply for this job now by sending your CV to Patricia.
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