AKRON, Ohio, USA
4 days ago
Quality Engineer - Manufacturing Life Sciences, Akron, OH

If you want to discover your greatest potential, Saint-Gobain provides one-of-a-kind opportunities for innovative problem solvers.

We're one of only two companies in the world that is consistently recognized as both a top Global Employer and a Top 100 Global Innovator, but Saint-Gobain's remarkable story and culture of innovation begins with a team of nearly 200,000 creative, diverse and passionate team members collaborating across the globe. We are committed to our mission to improve lives because, every day, we witness the enormous impact of our efforts on the world around us.

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

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