Senior Supplier Quality Engineer — Medical Devices

Boston Scientific; Arden Hills (MN); On-site; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific is seeking a Senior Supplier Quality Engineer in Arden Hills, MN to lead direct materials acquisitions quality activities. You will drive supplier quality improvements, lead audits, manage CAPAs, and collaborate across Quality, Sourcing, R&D, and Operations to ensure patient safety and compliant manufacturing.

The role emphasizes on-site engagement with suppliers, change management, and ensuring robust quality systems across the acquired entity.

Qualifications

• BS degree in engineering or technical field with minimum of 5 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%.

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.
• 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.

Job description

Boston Scientific is seeking a Senior Supplier Quality Engineer in Arden Hills, MN to lead direct materials acquisitions quality activities. You will drive supplier quality improvements, lead audits, manage CAPAs, and collaborate across Quality, Sourcing, R&D, and Operations to ensure patient safety and compliant manufacturing.

The role emphasizes on-site engagement with suppliers, change management, and ensuring robust quality systems across the acquired entity.