Senior Supplier Quality Engineer A great opportunity has arisen for a Senior Supplier Quality Engineer to join a dynamic team in Swords, Co. Dublin.
This role offers the chance to work in an innovative production and quality network, contributing to the delivery of high-quality products that support laboratories worldwide.
Key Responsibilities: Serve as a key connection between Supplier Quality, Quality Assurance, Manufacturing Engineering, R&D, Production, and Documentation Control.
Evaluate supplier capabilities to meet quality standards through data analysis and supplier audits, creating concise reports to drive improvements and corrective actions.
Utilize statistical analysis to support suppliers and enhance regulatory compliance, implementing world-class supply chain processes in a low-volume, high-complexity environment.
Collaborate with suppliers on areas including First Articles, quality and regulatory requirements, root cause investigations, corrective & preventive actions, and supplier performance reviews.
Monitor key supplier quality metrics and facilitate continuous improvement initiatives.
Qualifications & Experience: Strong background in Quality Management Systems within a regulated environment.
Experience leading projects to manage supplier quality, drive product and process evaluations, and implement process improvements.
Proven track record in supplier process enhancements and quality system updates, balancing compliance with efficiency.
A Bachelor's degree in a relevant technical field such as Quality, Engineering, or Science.
8+ years of experience in a regulated industry, with knowledge of FDA regulations, risk management, and writing/reviewing quality-related documentation.
Key Skills & Attributes: A proactive and driven individual passionate about developing and delivering high-quality solutions in collaboration with suppliers and key stakeholders.
Strong leadership and influencing skills to drive projects to completion.
Systems-level thinking with the ability to develop structured, concise technical documentation.
Expertise in statistical analysis and design of experiments, with experience using software such as Minitab.
Proficiency in MS Office (Word, Excel, PowerPoint, Project) and familiarity with product lifecycle management tools (e.g., SAP, Teamcenter).
Excellent presentation and communication skills, capable of delivering complex information clearly and persuasively.
Understanding of immunology, biochemistry, or hematology diagnostic technologies would be an advantage.
This is a fantastic opportunity for an experienced Supplier Quality Engineer to play a key role in a fast-paced, collaborative environment, ensuring high standards of quality and regulatory compliance.
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