Quality Engineer - P2 (Defined Term)

Provide Process/Quality Engineering support to manufacturing, helping to ensure delivery of highest quality product to the customer. Provide Process/Quality Engineering support to product development teams, helping to ensure development of highest quality new products. Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by 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 & documenting release criteria. Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members. May be responsible for creating risk analyses and FMEAs. Develops Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation in order to reduce/eliminate the cause of defects. Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development. 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. Evaluates the adequacy and compliance of systems, operations, and practices against regulation and company documentation. Could serve as auditor of areas of the BSC quality system, such as development and manufacturing, as assigned. Responsible for the final Process Monitor Release for products prior to distribution. 2-5 years' experience in Manufacturing or Quality with a honours degree qualification in Engineering or related technical/Quality discipline. Excellent written and verbal communication skills Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems Strong command of MS Office - Word, Excel, PowerPoint. Ability to rapidly learn and use new applications Previous experience in a Quality, or Manufacturing background. Experience in the medical device industry. Working knowledge and understanding of FDA, ISO13485, and the medical device industry quality requirements associated with manufacturing and supplier controls. Experience in problem solving and process improvement methodologies. Process Validation, Risk Management, CAPA experience.