Insight Global is looking for a Senior Supplier Quality Engineer who will support global sourcing, manufacturing operations, and global quality systems by participating in global communities of practice and value improvement projects. Leads supplier audits to ensure compliance with regulatory standards, including scheduling, reporting, and follow-up actions. Conducts on-site assessments and supports evaluation of supplier changes. Applies data-driven problem-solving to resolve complex quality issues, communicates findings, and approves corrective actions. Serves as a technical lead in Global Sourcing teams, driving category objectives and strategy. Independently leads cross-functional projects to improve quality systems and processes, mentors junior engineers, and recommends updates to the Quality Management System. Builds strong relationships across teams and with suppliers to support project goals and influence business decisions. Maintains a strong commitment to patient safety and product quality by ensuring compliance with the Quality Policy and fostering a culture of quality. 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.
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-Bachelor's degree in Chemistry, Biochemistry, chemical engineering or related field
- 5+ years of experience in pharmaceutical or drug combination products
-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.
Strong knowledge of FDA 21 CFR 820 and CFR 210/211.
-Experience in global supplier management, ISO 13485, ISO 9001 strongly desired.
-Supplier quality experience
-Experience with manufacturing support or process development.
Ideally someone with experience in aseptic processes.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.