Sustaining Engineering: Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues. Reviews and approves supplier corrective action plans and verification of effectiveness documentation. Manages sustaining quality issues, process change impacts, and design change implementations for suppliers. Investigates and solves material non-conformances due to incoming inspection. Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers. Supports and performs Supplier Change Impact Assessments for process changes at suppliers. Supports projects and consistently hits project milestones. Creates crisp and clear project plans and develops strong contingency plans as part of project planning process. Support the execution of supplier quality deliverables and collaborate with cross-functional new product development teams to onboard component suppliers. Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. BS degree in engineering or technical field with 2-4 years of progressive engineering experience. Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry. Project management: ability to influence cross functional global teams spanning Quality, Operations, R&D, and Sourcing. Experience in process validation, design controls, risk management, CAPA, SCAR. Ability to work independently; organized and self-driven. Articulate communicator; adept at packaging and appropriately scaling information to the intended audience. Ability to rapidly learn and use new software applications (e.g., PLM, ERP). Domestic and international travel up to 20%. Medical Device Industry experience Problem Solving and Project Management experience Experience on materials or service commodity team. Lead auditor of quality systems experience (ISO 13485 or similar). IPC-600 certified but no essential
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