Senior Quality Engineer
Posted on Oct 2, 2021 by Real Staffing Group
My client in Cork who is a medical Device multinational are looking for a Senior Quality Engineer with NPI to join their team on a 18 month contract with possibility to go perm.
Title: Senior NPI Quality Engineer
Location: Macroom, Cork
Benefits: Excellent salary, pension, healthcare and yearly bonus
- Work in a cross functional team with Project Management, Process Development (PD), R&D, Design Quality, Operations and Supplier Management to ensure successful launch of the new product.
- Ensure all process changes/process improvements are risk assessed by promoting the GO SEE Principle and FOCUS ON PROCESS Principle.
- Provide feedback to the R&D teams to ensure the new product is designed for manufacturing.
- Drive risk reduction and eliminate risks and introduce error proofing through the Risk Management process.
- Develop and agree with the master validation strategy for the new product manufacturing process.
- Review and approval of all process characterisation, process validation & test method validation documentation.
- Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (eg Use of DOE studies, FMEA's).
- Complete Attribute TMV's on new product projects.
- Ensure compliance at all stages of Product Lifecycle Development Process. Reviewer of change notices for product, process and system changes, validation builds and eCAPA phases. Promote a right first time behaviour within the New Product Project Teams.
- Provide regular updates to site management on progress of new product introduction activities.
- Support the compilation of documentation for Regulatory submissions for new products.
- Ensure that there is clear handover of quality responsibilities from the Project team to the SBSC cork Operations team.
- Ensure the line is set-up meeting the site 5S and cGMP requirements
- Ensure all Non-conformances and CAPA's are completed in a timely manner.
- Support the internal audit program.
- Requires a minimum level 8 relevant Engineering/Science degree
- Experience in NPI
- Minimum of 3+ years' experience within Quality department in medical device or pharmaceutical manufacturing industry
Would you be interested in having a chat about this role further?
If so forward me your up to date CV or let me know a time that works for you to take a call and we can set it up.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales