Senior Supplier Quality Engineer - Medical Devices (Onsite MN)

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

Job summary

Boston Scientific Corporation in Arden Hills, MN is seeking a Senior Supplier Quality Engineer for Direct Materials Acquisitions. You will lead supplier quality activities, plan audits, and drive CAPA and change management in a regulated medical device environment.

The role requires a BS in engineering, 5+ years of relevant experience, and ability to influence cross-functional teams globally. Travel up to 25% is expected as part of supplier assessments and on-site visits.

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.

Responsibilities

• Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues.
• 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.
• Plans and leads supplier audits to assess compliance with regulatory standards and Boston Scientific requirements.
• Supports Design Quality Assurance with Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues.

Skills

Project management

Communication

Independent worker

Software adaptability

Travel readiness

Education

BS in engineering or technical field

Tools

PLM

ERP

Job description

Boston Scientific Corporation in Arden Hills, MN is seeking a Senior Supplier Quality Engineer for Direct Materials Acquisitions. You will lead supplier quality activities, plan audits, and drive CAPA and change management in a regulated medical device environment.

The role requires a BS in engineering, 5+ years of relevant experience, and ability to influence cross-functional teams globally. Travel up to 25% is expected as part of supplier assessments and on-site visits.