Sr. Supplier Quality Engineer

Boston Scientific; Maple Grove (MN); On-site; USD 85,000 - 161,500; Full time

Job summary

Boston Scientific is looking for a Sr. Supplier Quality Engineer in Maple Grove, Minnesota, to enhance supplier performance and quality compliance. The role involves leading audits, supporting global sourcing, and driving improvements in quality systems.

Applicants should hold a BS degree in Engineering with at least 5 years of relevant experience, including knowledge of FDA regulations. The position offers a dynamic work environment and a comprehensive salary range between $85,000 and $161,500.

Qualifications

• Minimum 5 years of relevant quality engineering experience.
• Strong knowledge of FDA 21CFR820 and CFR210/211.
• Experience in component manufacturing or raw material production.

Responsibilities

• Plans and leads audits of suppliers for compliance.
• Develops solutions to complex problems based on data.
• Leads cross-divisional and cross-functional projects.

Skills

Effective communication

Critical thinking

Teamwork

Knowledge of FDA regulations

Independence

Education

BS degree in Engineering or similar

Job description

Recruiter

Spencer Gregory Hale

Sr. Supplier Quality Engineer

About this role

The Supplier Quality Engineer will play a key part in leading performance improvement of suppliers and increasing suppliers' capabilities to consistently meet Boston Scientific's requirements. Additionally, the Supplier Quality Engineer will support global sourcing, manufacturing operations, and global quality systems by participating in global communities of practice and value improvement projects. The North America MN Supplier Quality Engineering team is looking for high‑energy, driven, passionate people who want to build an amazing career.

Drives improvement and corrective action in the quality of components sourced from outside suppliers. Provides technical support in the selection of suppliers. Develops acceptance criteria for materials. Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.

Your responsibilities will include

• Plans and leads audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including audit scheduling, investigation, and evaluation of audit observations and findings, reporting, follow‑up, and confirmation of follow‑up actions. Proactively assesses supplier capabilities through direct on‑site visits and technical discussions and supports the evaluation of proposed changes at suppliers.
• Develops solutions to complex problems by evaluating data and selecting methods within defined practices and policies. Communicates quality issues to suppliers, applies systematic problem‑solving methodologies, and reviews and approves supplier corrective action plans and effectiveness documentation.
• Actively engages in Global Sourcing category teams as a technical lead, establishing and executing Global Sourcing category objectives.
• Leads cross‑divisional and cross‑functional projects that deliver improvements to quality systems and processes.
• Works under minimal direction regarding the direction and progress of projects and special assignments. Independently determines and develops innovative approaches to solutions. Interprets, executes, and recommends modifications to the Quality Management System. Provides leadership and mentorship to junior engineers. Work is reviewed upon completion for adequacy in meeting strategic objectives and alignment with company goals.
• Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Interacts with suppliers. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represent a specialized field in larger project teams. Influences middle management on business solutions.
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures. Ensures that appropriate resources, including personnel and tools, are available to support Quality System compliance and adherence to the Quality Policy. Fosters a work environment that upholds the Quality Policy and Quality System.

What we're looking for in you

Minimum requirements

• BS degree in Engineering or similar with a minimum of 5 years of relevant quality engineering experience.
• Experience in various component manufacturing or raw material production.
• Communicates effectively and concisely and delivers key points; appropriately scales communication style and depth according to the audience.
• Ability to influence cross‑functional global teams spanning Design Quality Assurance, R&D, Regulatory, Supplier Engineering, and Sourcing.
• Builds strategic and trusting relationships through demonstrated technical capability, critical thinking, and teamwork behaviors.
• Ability to work independently and collaborate with project teams; organized and self‑driven.
• Strong knowledge of FDA 21CFR820 and CFR210/211.
• Ability to work in a matrixed environment.
• Travel up to 10% of the time.

Preferred Qualifications

• Experience in global supplier management, ISO13485, ISO9001 strongly desired.
• Experience with manufacturing support or process development.
• Experience with project management.

Salary and Benefits

Minimum Salary: $85,000
Maximum Salary: $161,500

Requisition ID

630616

Equal Employment Opportunity Statement

Boston Scientific Corporation is an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Boston Scientific maintains specific prohibited substance test requirements for safety‑sensitive positions. This role is deemed safety‑sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.