Quality Engineer - Manufacturing Life Sciences, Akron, OH

Why do we need you ? Sciences division, teams are solving critical problems for customers who are getting life-saving medical devices to the frontlines of healthcare, discovering essential medications, and nourishing and connecting the world through consumer, industrial and electronics applications. As one of the world's leading producers of high-performance polymer products, we improve lives by making simple experiences better and being there in life's critical moments. Our team members recognize that we all create the environment for people to succeed, with a culture built on respect, open and honest communication, and honoring our commitments to our customers and each other. And at the heart of our culture, we've learned working together makes good ideas, great ones. With a legacy dating back more than 350 years, Saint-Gobain offers employees the stability and security of a leading Global 500 corporation while operating like multiple small and agile start-ups, where entrepreneurial spirit, pioneering teamwork, and bold, forward-thinking ideas pave new paths. Every team member is encouraged to develop and leverage their unique expertise and strengths to make the greatest impact on the company and our end users. At Saint-Gobain, you're empowered and equipped with countless opportunities and resources for professional development. You will find the support you need to create a vision and roadmap for your career, and make that vision a reality. Invent yourself at Saint-Gobain Life Sciences; and together, we'll create a better life. JOB SUMMARY AND PURPOSE The Quality Engineer I will support the Quality Manager to ensure that the Quality Management System and quality standards of the company are implemented and maintained at the Akron facility in accordance with corporate quality policies, applicable regulatory requirements, ISO requirements, and customer specifications/expectations. ESSENTIAL FUNCTIONS AND RELATED OBJECTIVES: * Support the development, implementation, and oversight of an effective Quality Management System that operates in compliance with corporate quality policies and procedures, and relevant regulatory requirements and industry guidance, including: o Change management and review of change controls o Investigation and CAPA management, including robust root cause analysis o Complaint management and performance of complaint investigations o Internal audit program and performance of internal audits o Training program; conduct training when needed o Preparation of Management Review materials/metrics o ISO certification and maintenance 60% * Support the oversight of product realization and commercial manufacturing activities, such as product/specification development, process capability, facilities/utilities/equipment qualification and maintenance, and materials management. 30% * Support the testing, review, and disposition process for production batches and incoming raw materials, including management of deviations and nonconforming product. 20% * Customer support, including: o Support customer audits o Product stewardship requests Is this job for you ? Education: Bachelor's Degree - Life Sciences or Engineering discipline - REQUIRED Licenses and Certifications: ASQ certifications (e.g. CQE, CQM, CQA) 3 Years - Preferred Work Experience: 3+ years - Regulated industry, such as life sciences, food and beverage, or aerospace with preferred emphasis in life sciences (e.g. pharma, biopharm, or medical device). - REQUIRED 1 year - Quality role (Quality System development, implementation, and/or execution) within a manufacturing environment - REQUIRED Employee is responsible to: * Know and understand the quality and safety policies. * Complete all quality and safety training required for the specific position. * Follow all quality and safety