Job Title: Medical Device Senior Supplier Quality Engineer
Job Location: Brooklyn Center, Minnesota (On-site)
Type: W2 contract
Job Description:
Responsibilities may include the following and other duties may be assigned. Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier related problems as they occur. Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met. Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
Partner with Technical Sourcing to locate, evaluate, and approve new potential component/material suppliers that balance business, quality, and technical requirements.
Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow provide customers with the highest quality and reliable products.
Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified PPAP requirements.
Work to develop proper inspection tooling and test methods for new components to ensure supplier parts meet specification requirements. Perform statistical data analysis to determine tool and part/process performance. Evaluate Supplier capabilities for mechanical measurement via Gage R&R studies. Ensure appropriate acceptance activities are in place prior to commercialization.
Plan, execute, and communicate own work and educating others on work products. Provide regular, timely communication to manager and project team regarding status of assigned activities.
Metrology & Measurement; statistical analysis (Cpk, standard deviation, etc.), measurement uncertainty, GD&T, Gauge Repeatability & Reproducibility
Must Have: Minimum Requirements:
Minimum Education:
Bachelor of Science in Mechanical Engineering, Chemical Engineering, Material Science, or a similar discipline.
quality control/engineering
manufacturing/product / mechanical engineering
driving projects to closure / DMAIC / CAPA experience.
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