Senior Quality Engineer (Defined Term)

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. Become a Subject Matter Expert for quality related queries in the Capital Equipment Repair Operations area Interacts cross functionally and with Internal and External Customers. Serves as the Clonmel point of contact for the BSC sites in Arden Hills, Penang and Kerkrade for quality process related discussions / issues Leads 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. Provides Quality Engineering support to ongoing Capital Equipment Repair Operations initiatives including product transfer projects and process alignment with sister sites Provides Quality System & External Audit support for Capital Equipment Repair 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. Leads/supports 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 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 more junior members of the team through a wide range of tasks from line support to project support Level 8 honours bachelor's degree within a relevant field. 5+ years' of experience working within a highly regulated environment. Medical Devices experience is desirable. 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.