Senior Supplier Quality Engineer - North Dublin

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.