Supplier QA Engineer III

Boston Scientific - Arden Hills, MN

Full-time - Mid Level

Arden Hills, MN

Miscellaneous Manufacturing

About the position

The Supplier Quality Engineer III will play a pivotal role in enhancing the performance and capabilities of suppliers to ensure they consistently meet the stringent requirements set by Boston Scientific. This position is integral to supporting global sourcing, supplier manufacturing operations, and global quality systems. The engineer will actively participate in global communities of practice and value improvement projects, contributing to the overall quality and efficiency of supplier operations. In this role, the Supplier Quality Engineer will assess suppliers for their technical, quality, and manufacturing capabilities. They will be responsible for the qualification and onboarding of suppliers, as well as monitoring their performance based on risk assessments. The engineer will also drive both reactive and proactive supplier projects and investigations, collaborating closely with Supplier Engineering, Commercial Sourcing, and Design Assurance teams. A significant aspect of the role involves investigating field failures related to supplier materials and developing corrective action plans when necessary. The engineer will be tasked with devising solutions to complex problems that require thorough analysis of data and evaluation of various identifiable factors. They will exercise authority and judgment in selecting appropriate methods and techniques for obtaining solutions, leveraging their broad knowledge of alternatives and their potential impacts on the business unit. The Supplier Quality Engineer III will plan and organize non-routine tasks, maintaining project schedules and priorities with general direction. They will independently determine approaches to solutions and interpret company policies, assisting in the establishment of departmental policies and procedures. Their work will be reviewed upon completion to ensure it meets the set objectives. Building and nurturing a wide range of business relationships is crucial for the successful completion of assignments. The engineer will interact with suppliers and participate in setting goals and objectives for projects. They may lead projects within their function or department and represent specialized fields in larger project teams, influencing middle management on business solutions. In all actions, the Supplier Quality Engineer III will demonstrate a primary commitment to patient safety and product quality, ensuring compliance with the Quality Policy and all documented quality processes and procedures. They will ensure that the necessary resources are maintained to uphold Quality System compliance and adherence to the Quality Policy, fostering a work environment that supports these principles.

Responsibilities

• Assess suppliers for technical, quality and manufacturing capabilities.
• Responsible for supplier qualification, onboarding and performance monitoring based on supplier risk.
• Assess & drive reactive as well as proactive supplier project(s)/investigations partnering with Supplier Engineering, Commercial Sourcing, Design Assurance.
• Investigates field failures related to supplier materials and develops corrective action plans where necessary.
• Develops solutions to a variety of complex problems of diverse scope and complexity.
• Plans and organizes non-routine tasks with approval, maintaining project schedules and priorities.
• Works under general direction regarding the direction and progress of projects and special assignments.
• Establishes and cultivates a wide range of business relationships to facilitate completion of assignments.
• Interacts with suppliers and 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.
• Contributes to the completion of specific programs and projects, ensuring timely results and resource management.

Requirements

• Bachelor's degree in engineering/technical field such as materials science, chemical or mechanical engineering and 5 years related experience or master's degree and 3 years related experience.
• Experience with problem solving quality tools and CAPA.
• Experience in working with mechanical or electrical suppliers.
• Experience with technical documentation.
• Ability to communicate cross functionally, with suppliers, team members and leadership.

Nice-to-haves

• Experience with or lead auditor certification to ISO13485, 9001, TS16949 standards.
• Experience with auditing supplier quality systems.