Supplier Quality Engineer II

Work mode: Hybrid

Onsite Location(s): Arden Hills, MN, US, 55112

Recruiter: Spencer Gregory Hale

Supplier Quality Engineer II

About this role

The Supplier Quality Engineer will play a key part in leading performance improvement of suppliers and increasing the supplier’s 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.

Your responsibilities will include:

• Assess suppliers for technical, quality and manufacturing capabilities through direct on-site visits and technical discussions. Assists in the evaluation of proposed changes at suppliers.
• Works cross-functionally in identifying and resolving technical issues. Maintains and enhances cross-functional team relationships within the divisions, plants, distribution centers, across the entire BSC network.
• Reviews and approves supplier corrective action plans and verification of effectiveness documentation.
• Evaluates supplier caused manufacturing yield issues, incoming quality issues, and field failures and applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving the issues.
• Develops and maintains incoming acceptance methods for materials and trains incoming inspectors to procedures.
• 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 department and represent a specialized field in larger project teams.
• Plans and leads audits of suppliers to assess compliance with regulatory and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.
• Monitors supplier performance to drive improvement and corrective action in the quality of components sourced from outside suppliers.
• Works in a category team environment to identify opportunities to set up acceptance methods at the suppliers and to consolidate materials at vendors according to category team strategy.

What we're looking for in you:
Minimum qualifications:

• Experience in process validation, design controls, risk management, and CAPA.
• Experience in medical device.
• Strong communicator; adept at packaging and appropriately scaling information to the intended audience.
• Ability to rapidly learn and use new software applications (e.g., PLM, ERP).
• Ability to work independently; organized and self-driven.
• Domestic and international travel up to 20%.
• Project management: ability to influence cross functional global teams spanning quality, operations, R&D, and sourcing.
• BS degree in engineering or related technical field with minimum of 3-5 years of relevant experience.

Preferred qualifications:

• Experience with medical device suppliers
• Experience as lead auditor of quality systems (ISO13485 or similar)
• Experience with quality systems and processes, and project management.
• ASQ certification (CQE, CBA, SSGB, SSBB).

Requisition ID: 564155

Among other requirements, Boston Scientific maintains specific drug testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.