Supplier Quality Assurance Engineer II - SFMD NMOD

Boston Scientific • Arden Hills, MN

399d

About The Position

The Supplier Quality Engineer II at Boston Scientific is responsible for ensuring the quality and safety of medical devices produced by external suppliers. This role involves collaborating with cross-functional teams to improve manufacturing processes, manage quality issues, and support new product development within the Sourced Finished Medical Device (SFMD) organization. The engineer will focus on Single-Use Devices and Capital Equipment accessories, ensuring compliance with regulatory standards and company policies.

Requirements

• BS degree in engineering or technical field with a minimum of 2 years of relevant experience.
• Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industries.
• Project management skills with the ability to influence cross-functional global teams.
• Experience in process validation, design controls, risk management, CAPA, and SCAR.
• Organized, self-driven, and articulate communicator.
• Ability to rapidly learn and use new software applications (e.g., PLM, ERP).

Nice To Haves

• 3+ years of medical device engineering 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.

Responsibilities

• Evaluate and communicate quality issues to suppliers, applying systematic problem-solving methodologies.
• Review and approve supplier corrective action plans and verify effectiveness documentation.
• Assess supplier capabilities through on-site visits and technical discussions.
• Coordinate evaluations of proposed changes at suppliers and lead supplier audits for compliance.
• Manage sustaining quality issues and process change impacts for suppliers within the quality system.
• Investigate and solve non-conformances due to incoming inspection at distribution centers.
• Support Design Quality Assurance with investigations on supplier-related quality issues.
• Support Supplier Change Impact Assessments for process changes at suppliers.
• Contribute to project planning and ensure milestones are met.
• Execute SFMD Plan deliverables for integration of acquired suppliers into the quality system.

Benefits

• Access to the latest tools, information, and training to advance skills and career.
• Support for professional development and career growth.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree