Our client is looking for a Sr. Supplier Quality Engineer to support the maintenance, management, and improvement of suppliers. This candidate will be tasked with owning the product qualification plan which includes identifying the component, features of the component, risk level, quality requirements, validation requirements, and then execution. Products are blended across Molding, Machine, Extrusion and Catheter components. Key Responsibilities include:
- Support component specification development, identification of critical features, development of inspection methods and plans, test method validation, and component capability assessments
- Lead risk management activities, including the development and implementation of FMEAs, process control plans, and quality agreements at suppliers.
- Support suppliers in the development, approval and execution of process validation protocols and reports for critical processes
- Utilize statistical techniques and six sigma tools to analyze processes and drive continuous improvement activities.
- Collect and analyze Quality metrics relating to Supplier Quality
The ideal candidate will have 5+ years of Supplier Quality Engineering, possess a background in NPD or Manufacturing engineering for medical devices and a complex understanding of technical documents including diagrams, parts specifications, and blueprints.
Supplier Quality, Quality Engineering, TMV, Process Validation, Device Development/Engineering, ISO 13485
Mechanical Engineering or related degree
CA: Supplier Quality Engineer x2 (234193)