Supplier Quality Engineer II - Direct Materials Acquisitions g - P2

Supplier Quality Engineer II – Direct Materials Acquisitions (P2)

Onsite Location(s):
Arden Hills, MN, US, 55112

Job Title:

Supplier Quality Engineer – Direct Materials Acquisitions

The Global Sourcing organization at Boston Scientific oversees a diverse network of suppliers that manufacture components or finished devices for BSC distribution. The Supplier Quality Engineer demonstrates a primary commitment to patient safety and collaborates with cross‑functional internal/external resources to continually improve supplier manufacturing processes. In this role, the focus is on components and applicable accessories within the acquisition space.

• Evaluate and communicate quality issues to suppliers; apply systematic problem‑solving methodologies to identify, prioritize, and resolve quality issues. Review and approve supplier corrective action plans and verify effectiveness documentation.
• Manage sustaining quality issues, process change impacts, and design change implementations for suppliers within the Acquired Entity Quality system, the hybridized BSC‑Acquired Entity Quality System, and the BSC Quality System after product integration.
• Proactively assess supplier capabilities through on‑site visits and technical discussions; coordinate the evaluation of proposed changes at suppliers.
• Plan and lead supplier audits to assess compliance with regulatory standards and Boston Scientific requirements, including scheduling, investigation, evaluation of audit observations and findings, reporting, follow‑up, and confirmation of follow‑up actions.
• Support Design Quality Assurance with Field Action and Product Inquiry Reports by performing investigations on supplier‑related or supplier‑caused quality issues.
• Investigate complaints and manage SCARs/NCEPs at component suppliers where the issue is manufacturing‑related.
• Support Supplier Change Impact Assessments for process changes at suppliers.
• Support and perform Finished Good Documentation changes in support of ongoing design changes or labeling updates.
• Lead projects and consistently hit milestones; create clear project plans and develop contingency plans as part of the project planning process.

• Support manufacturing lines of acquired entity by integrating acquired company’s suppliers and products into BSC’s Quality System.
• Lead the execution of material controls quality deliverables and collaborate with cross‑functional new product development teams to onboard suppliers.
• Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.

• Support Material Controls external regulatory body audit requests as required.
• Lead or support Material Controls internal audit efforts.
• Collaborate with corporate and regional supplier quality organizations on policy, procedure, and guideline development; include generation, review, and implementation of these documents.
• Identify and advise management on potential improvements to quality systems and processes.
• Champion 100 % compliance with company policies and SOPs.

• BS degree in engineering or a technical field with a minimum of 2 years of relevant experience.
• Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.
• Project management experience; ability to influence cross‑functional global teams spanning Quality, Operations, R&D, and Sourcing.
• Experience in process validation, design controls, risk management, CAPA, and SCAR.
• Ability to work independently; organized and self‑driven.
• Articulate communicator; adept at packaging and 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 %.

• 7 + years of medical device engineering experience.
• Medical device industry experience.
• Drug or animal tissue experience.
• Problem‑solving and project management experience.
• Leadership experience on a materials or service commodity team.
• Lead auditor of quality systems…