Supplier Quality Engineer II - SFMD Neuromodulation

Recruiter: Spencer Gregory Hale Supplier Quality Engineer II - SFMD Neuromodulation About the role: The Sourced Finished Medical Device (SFMD) organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Supplier Quality Engineer II will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our supplier’s manufacturing processes. In this role, you will support SFMD products associated with the Nalu acquisition associated with the Neuromodulation division. Your responsibilities include: 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. * Proactively assesses supplier capabilities through direct on-site visits and technical discussions. Coordinates the evaluation of proposed changes at suppliers. * Plans and leads supplier audits to assess compliance with regulatory standards and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions. * Manages sustaining quality issues, process change impacts, and design change implementations for the supplier, Nalu. * Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers. * Supports Design Quality Assurance with Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues. * Investigates complaints and manages NCEPs at OEM suppliers and CM suppliers where the issue is manufacturing-related. * Supports Supplier Change Impact Assessments for process changes at suppliers. * Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates. * Supports projects and contributes to consistently hitting project milestones. Collaborates on developing crisp and clear project plans and strong contingency plans as part of project planning process. New Product Development: * Execute SFMD Plan deliverables for launch of Nalu’s products into BSC’s Quality System. * Support the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers. * Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations. Quality System Champion: * Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development. Includes generation, review, and implementation of these documents. * Identifies and advises management on potential improvements to quality systems and processes in the company. * Champions 100% compliance to company policies and SOP’s. What we’re looking for in you: Minimal Qualifications: * BS degree in engineering or technical field with minimum of 2 years of relevant 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. * 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 25%. Preferred Qualifications: * 3+ years of medical device...