Supplier Quality Engineer III - External Operations ENDO

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.

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 audit 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 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:

• MS Degree in engineering
• 5+ years of medical device engineering experience preferred, in a design, manufacturing or supplier quality related role.
• Medical Device Industry experience
• Problem Solving and Project Management experience
• Leadership experience on a materials or service commodity team.
• Lead auditor of quality systems experience (ISO 13485 or similar).
• ASQ certification (CQE, CBA, SSGB, SSBB) desired.
• Working knowledge of EU MDR, FDA QMSR, IEC 60601, and ISO 14971