Supplier Quality Engineer III - External Operations ENDO

Recruiter: Spencer Gregory Hale Supplier Quality Engineer III – External Operations ENDO Boston Scientific's hybrid workplace incorporates an onsite 3 day minimum with optional 2 remote days. By applying to this position, you will be located and reporting to the corporate site in Marlborough, MA. Remote Eligible: Hybrid Onsite Location(s): Marlborough, MA About the role: The External Operations organization focuses on Sourced Finished Medical Device (SFMD) at Boston Scientific and is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Supplier Quality Engineer III 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 within Endoscopy division with a primary focus on Single-Use Devices and Capital Equipment. Additionally, the resource will support medical and non-medical accessories or products. 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 suppliers within the BSC quality system requirements as well as supporting any requirements from the supplier’s Quality system. * Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers. * Supports Design Quality Assurance with post market signals, 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, CM suppliers and other categories of 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. * Leads projects and consistently hits project milestones. Creates crisp and clear project plans and develops strong contingency plans as part of project planning process. * Leads and/or supports continuous improvement opportunities to drive efficiency and effectivity at BSC points of use. New Product Development: * Execute SFMD Plan deliverables for integration and/or onboarding of supplier and related products into BSC’s Quality System. * Lead 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: * Supports Material Controls external regulatory body audits requests as required. * Leads or supports Material Controls internal audit efforts. * 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...