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Senior Quality Engineer

Real Staffing Group

Posted on Oct 2, 2021 by Real Staffing Group

Macroom, Cork, Ireland
Research
Immediate Start
Annual Salary
Full-Time


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


Responsibilities:



  • 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.


Requirements:



  • 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




Reference: 1343099962

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