Supplier Quality Engineer II - Direct Materials Acquisitions

Supplier Quality Engineer II - Direct Materials Acquisitions

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

Recruiter: Spencer Gregory Hale

Supplier Quality Engineer – Direct Materials Acquisitions

About the role: The Global Sourcing organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers that manufacture components or finished devices for BSC distribution. The Supplier Quality Engineer 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 products within the acquisition space with a primary focus on components and applicable accessories.

Your responsibilities include:

• 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 within the Acquired Entity Quality system, the hybridized BSC-Acquired Entity Quality System, and in the BSC Quality System after products are successfully integrated.
• 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.
• 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 SCARs/NCEPs at component 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.

New Product Development:

• Support manufacturing lines of acquired entity’s manufacturing line through integration of 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.

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 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.
• 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 25%.

Preferred Qualifications:

• 7+ years of…