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 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 with minimum of 3+ years of relevant experience in supplier interaction, quality systems, or regulated processes.

* Experience…