Supplier Quality Engineer II - Direct Materials Acquisitions

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 which manufactures 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:

Supplier/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 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 medical device…