Quality Engineer - P3

Provide expert support to Capital Equipment Repair Team as required helping to ensure delivery of highest quality product. Provide Process/Quality Engineering to support new product introduction to the site, helping to ensure development of highest quality new products. Subject Matter Expert for quality related queries in the SpyScope Manufacturing Operations area. Interacts cross functionally and with Internal and External Customers. Serves as a Clonmel point of contact for the BSC sites in Marlborough and Spencer for quality process related discussions / issues. Lead the resolution of Quality Related issues for the area by leading / participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions. May be responsible for querying & bounding data to support implementation of complex corrections / corrective actions & documenting release criteria. Leads projects & process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance and sustain Quality Metric performance in the area (including Best 4 strategic projects, Quality Catch Ownership, Project Prioritisation, WSVA, IQS, VIP) Provides Quality Engineering support to ongoing Engineering & Operations initiatives including process alignment & improvements, MES. Leads the implementation of improvement projects from a quality perspective. Manufacturing Quality representative for Design Change and Implantable Build Readiness activities Competent knowledge of Process Monitoring approach Provides Internal & External Audit support for Engineering & Operations. Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Responsible for external audit preparation activities for the area. Assists in creation of Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, and by helping to identify more effective tools & materials. Coaches junior members of the team through a wide range of tasks from line support to project support. Knowledge of product labelling systems at Clonmel site Bachelors' honors degree within a relevant field. 6+ years of experience working within a highly regulated environment. Medical Devices experience is desirable. Mentorship of junior team members. Must have a strong vision and an ability to influence the organization in the direction of Quality & Compliance. The successful candidate must be a self-starter with the ability to work on own initiative, while possessing strong team player characteristics. Strong communication skills required.