Supplier Quality Engineer III

3 weeks ago

Littleton, United States Insight Global Full time

Insight Global is looking for Supplier Quality Engineers, for a top client in the medical device industry, to sit in the clients Littleton, Colorado facility five days a week. The Supplier Quality Engineer will be dedicated to the client's newest product expecting to launch in 2024. The position requires candidates with strong supplier audit experience, from auditing the suppliers, being a driving force in the event changes of suppliers are necessary as well as corrective actions. Additional responsibilities will include: Supports relationship with key suppliers and acts as Point of Contact for resolution of technical issues and quality concerns Functions as a member of the Supplier Engineering Team working cross-functionally and proactively on supplier quality and management activities. These activities include:Tool Design and Process Development that drives zero defect approach to qualityNew Product Introduction (NPI)Area of concentration includes Injection Molding and ExtrusionComponent, tooling, and process validations / verificationProject management of supplier quality initiativesSupplier selection, evaluations, and auditsCorrective and Preventative Action (CAPA) and Nonconforming Materials (NC)Perform independent evaluation, selection, and application in making adaptations and modifications to projects. Receives assigned total project leadership responsibilities on a portion of major significant projects and will be given total management responsibility for smaller projects. Manages and provides leadership for the functional group's development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives. Implements and understands FDA or regulatory requirements as necessary. Applies technology principles to multiple tasks. Working knowledge of cross-functional and related technical areas. Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources. Advises team members pro-actively on technical ideas and promotes skill development of team work. Interacts with peers across projects to secure resources and commitments. Handles frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects. Follows technical specification requirements and provides feedback on various technical processes and procedures. Presents effectively complex technical information/analysis, and responds to questions from technical staff members and management. 10+ years of supplier audit experienceSupplier Quality experience for new products Two years of GMP manufacturing experienceMedical Device experience4+ years of injection molding, or extrusion or device manufacturing experience

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