Supplier Quality Engineer III - Drugs Categories

Apply for the Supplier Quality Engineer III - Drugs Categories role at Boston Scientific

Recruiter:
Spencer Gregory Hale

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!

• 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. Work is reviewed upon completion for adequacy in meeting strategic objectives and alignment with company goals.
• 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.

• 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.

• 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.

Requisition : 620765

Minimum Salary: $76,000

Maximum Salary: $144,400

The anticipated…