Supplier Quality Engineer III - Drugs Categories

Supplier Quality Engineer III - Drugs Categories

The Supplier Quality Engineer will play a key part in leading performance improvement of active pharmaceutical ingredients (API), excipient 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.

The North America MN Supplier Quality Engineering team is looking for high-energy, driven, passionate people, looking to not just change jobs, but start 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 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 innovative approaches to solutions. Interprets, executes, and recommends modifications to the Quality Management System. Provides leadership and mentorship to junior engineers.

What we're looking for in you: Minimum requirements: BS degree in Chemistry, Biochemistry, chemical engineering, Materials Science or similar with 3+ years of relevant experience. 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. Ability to work independently and collaborate with project teams; organized and self-driven. Experience in global supplier management, ISO 13485, ISO 9001 Strong knowledge of FDA 21 CFR 820 Ability to work in a matrixed environment. Travel up to 10% of the time. Preferred Qualifications: Experience in pharmaceutical or drug combination products. Experience with manufacturing support or process development. Experience with project management. Ideally someone with experience in aseptic processes. Knowledge of and CFR 210/211