Sr. Supplier Quality Engineer - Electronics

Boston Scientific•Arden Hills, MN

2d•$85,000 - $161,500

About The Position

The Supplier Quality Engineer will improve supplier performance and capabilities so suppliers consistently meet Boston Scientific’s requirements. The role collaborates with cross-functional teams to resolve component-related challenges across the supply chain, including receiving inspection, manufacturing, testing, and assembly into finished goods. It also supports global sourcing, manufacturing operations, and global quality systems through participation in global communities of practice and value improvement projects. The position drives supplier component quality improvement and corrective action, provides technical input in supplier selection, develops material acceptance criteria, and monitors supplier performance to address corrective actions, manufacturing yield issues, and field failures. Working under minimal direction, the engineer independently develops solutions, leads projects, provides mentorship to junior engineers, and builds business relationships with suppliers and internal stakeholders. The position requires a primary commitment to patient safety and product quality, compliance with the Quality Policy and documented processes, and helping ensure resources are available to maintain Quality System compliance.

Requirements

Bachelor of Science degree in Engineering or a similar field.
At least 5 years of relevant quality engineering experience.
Experience with component manufacturing or raw material production.
Effective, concise communication skills, with the ability to tailor communication style and detail to the audience.
Ability to influence global cross-functional teams spanning Design Quality Assurance, R&D, Regulatory, Supplier Engineering, and Sourcing.
Ability to build strategic, trusting relationships through technical capability, critical thinking, and teamwork.
Experience with Quality Management Systems, including ISO 13485, FDA 21 CFR 820, and ISO 9001, as well as regulatory compliance and risk management.
Experience with quality problem-solving tools, Corrective/Preventive Actions (CAPA), and technical documentation.
Ability to work independently and collaboratively with project teams; organized and self-driven.
Ability to travel domestically and internationally up to 10%.

Nice To Haves

Lead auditor certification to ISO 13485, ISO 9001, or TS 16949 standards.
Experience with manufacturing support or process development.
Experience with project management.

Responsibilities

Plan and lead supplier audits, including scheduling, investigation and evaluation of findings, reporting, follow-up, and confirmation of follow-up actions.
Assess supplier capabilities through on-site visits and technical discussions, and support evaluation of proposed supplier changes.
Communicate quality issues to suppliers, apply systematic problem-solving methods, and review and approve supplier corrective action plans and effectiveness documentation.
Investigate field failures related to supplier materials and develop corrective action plans where necessary.
Assess and drive reactive and proactive supplier projects and investigations in partnership with Supplier Engineering, Manufacturing/Test Operations, Commercial Sourcing, Design Assurance, and R&D.
Participate as a technical lead in Global Sourcing category teams and establish and execute category objectives.
Lead cross-divisional and cross-functional projects to improve quality systems and processes.
Independently determine and develop approaches to solutions, interpret and recommend modifications to company policies, and assist in establishing departmental policies and procedures.
Provide leadership and mentorship to junior engineers.
Establish and cultivate business relationships, interact with suppliers, participate in project goal-setting, and influence middle management on business solutions.
Maintain compliance with the Quality Policy and documented quality processes and procedures, and foster a work environment that supports Quality System compliance and patient safety.