Sr. Supplier Quality Engineer - Electronics

About this role

The Arden Hills Supplier Quality Engineering team is looking for high-energy, driven, passionate people, looking to not just change jobs, but start an amazing career! The Supplier Quality Engineer will play a key part in leading performance improvement of suppliers and increasing supplier's capabilities to consistently meet Boston Scientific's requirements. This role collaborates with cross-functional teams to address and resolve all component-related challenges throughout the supply chain including receiving inspection, manufacturing, testing, and assembly into finished goods. 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. 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 a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors.
• Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Communicates quality issues to suppliers, applies systematic problem-solving methodologies, and reviews and approves supplier corrective action plans and effectiveness documentation.
• Has a broad knowledge of a variety of alternatives and their impact on the business unit.
• Investigate field failures related to supplier materials. Develop corrective action plan where necessary.
• Assess & drive reactive as well as proactive supplier project(s)/investigations partnering with Supplier Engineering, Manufacturing/Test operations, Commercial Sourcing, Design Assurance, R&D.
• Actively engaging 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 approach to solutions.
• Interprets, executes and recommends modifications to company policies. Assists in establishing departmental policies and procedures.
• Provides leadership and mentorship to junior engineers.
• 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, demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures.
• Ensure that appropriate resources, including personnel and tools, are available to support Quality System compliance and adherence to the Quality Policy.
• Foster 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 minimum of 5 years of relevant quality engineering experience.
• Experience in various component manufacturing or raw material production.
• Communicates effectively and concisely pack up information to deliver 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.
• Experience in Quality Management Systems (ISO 13485, FDA 21 CFR 820, ISO 9001), regulatory compliance, and risk management.
• Experience with problem solving quality tools, Corrective/Preventive Actions (CAPA), Technical Documentation.
• Ability to work independently and collaborate with project teams; organized and self-driven.
• Domestic and international travel up to 10%.

Preferred Qualifications

• Lead auditor certification to ISO13485, 9001, TS16949 standards.
• Experience with manufacturing support or process development.
• Experience with project management.