Sr. Supplier Quality Engineer - Direct Materials Acquisitions

Recruiter: Spencer Gregory Hale

 

 

Senior Supplier Quality Engineer – Direct Materials Acquisitions 

 

Onsite/Hybrid Location(s): Marlborough, MA; Minneapolis, MN; or Dorado, Puerto Rico 

  

About the role: 
The Global Sourcing organization at Boston Scientific is a global, passionate team that oversees a diverse network of suppliers which manufacture finished devices for BSC distribution. The Senior 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 Elutia acquisition in the Cardiac Rhythm Management division with a primary focus on implantable products and applicable accessories. 

 

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. 

• 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 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. 

• 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.