Senior Supplier Quality Engineer - North Dublin.
Key tasks and responsibilities: As a key member of the team, you will be part of a highly innovative Production and Quality network working to deliver high quality products.
Act as a key liaison and knowledge transfer champion among Supplier Quality, Quality Assurance, Manufacturing Engineering, R&D, Production, and Documentation Control.
Assess suppliers' capability to meet quality requirements based on data analysis and supplier audits.
Create concise reports that enable project teams to implement improvements and corrective actions.
Use statistical analysis to support suppliers and drive regulatory standards of excellence.
Develop world-class supply chain processes to suit a low volume, high complexity multi-technology environment.
Work with suppliers in a wide range of Quality relevant areas such as First Articles, general Quality and Regulatory requirements.
Collaborate with suppliers on Corrective & Preventative Actions, Root Cause Investigations, conduct Supplier Performance Reviews, and reporting of Key Supplier Quality metrics.
Interested applicants should have: Proven experience in Medical Devices QMS to develop world-class supply chain processes to suit a low volume, high complexity multi-technology environment.
Led projects to manage suppliers to deliver quality products to internal customers through product & process investigations & evaluations.
Identified and driven process improvements with suppliers.
Focused on and been responsible for supplier process improvements and updating quality system procedures to achieve both fully compliant and lean processes with suppliers.
Minimum of a Bachelor's degree in a relevant technical discipline (ideally Quality, Engineering, or Science).
At least 8 years of relevant experience in a regulated environment with a core appreciation of FDA regulations and Risk Management including writing and/or reviewing Quality related procedures, plans, and reports.
Strong leadership skills and ability to influence cross-functional teams to drive workscope to completion.
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