External Operations: Supplier Quality Engineer II

Boston Scientific Corporation; Marlborough (MA); On-site; USD 75,000 - 143,000; Full time

Job summary

Boston Scientific Corporation, Marlborough, MA, is seeking a Supplier QA Engineer II–External Operations ENDO. The role focuses on SFMD supplier quality, audits, and continuous improvement within the Endoscopy division's single-use devices and capital equipment.

You will lead supplier quality activities, on-site assessments, and change control per regulatory standards, with travel up to 25%. Hybrid onsite with a minimum 3 days in office and optional 2 remote days.

Qualifications

• BS degree in engineering with minimum of 1+ 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%.

Responsibilities

• 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 effectiveness at BSC points of use.

Skills

Project management

Quality systems

CAPA/SCAR

Auditing

Cross-functional collaboration

Communication

PLM/ERP software

Education

BS degree in engineering

Tools

PLM

ERP

Job description

Boston Scientific Corporation, Marlborough, MA, is seeking a Supplier QA Engineer II–External Operations ENDO. The role focuses on SFMD supplier quality, audits, and continuous improvement within the Endoscopy division's single-use devices and capital equipment.

You will lead supplier quality activities, on-site assessments, and change control per regulatory standards, with travel up to 25%. Hybrid onsite with a minimum 3 days in office and optional 2 remote days.