Senior Supplier Quality Engineer
2 weeks ago
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.
- 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.
- 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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