Quality Engineer II - Manufacturing, Life Sciences - ...

Why do we need you ? If you want to reshape the world and 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 II will support the Quality Manager to ensure that the Quality Management System and quality standards of the company are implemented and maintained at the Saint Gobain Life Sciences Akron facility in accordance with corporate quality policies, applicable regulatory requirements, ISO requirements, and customer specifications/expectations. Key Accountabilities Manage 3 Quality Technicians on 3 different shifts Lead and/or 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: - Document control and review/approval of controlled documents - Change management and review of change controls - Investigation and CAPA management, including robust root cause analysis - Complaint management and performance of complaint investigations - Supplier quality management and performance of supplier audits as appropriate - Internal audit program and performance of internal audits - Training program; conduct training when needed - Implementation of Quality Risk Management in relevant aspects of the QMS - Management Review - ISO certification and maintenance Lead and/or support the oversight of product realization and commercial manufacturing activities, such as product/specification development, tech transfer, validation, process capability, facilities/utilities/equipment qualification and maintenance, and materials management. Support the testing, review, and disposition process for production batches and incoming raw materials, including management of deviations and nonconforming product. Customer support, including: - Support customer audits, including response and corrective action tracking - Partner in the resolution of quality issues and customer requests by initiating effective interdepartmental communication. Is this job for you ? Education: Bachelor's degree in Life Sciences or Engineering - REQUIRED License/Certification: ASQ certifications (CQE, CQM, CQA) - PREFERRED Work Experience: 5+ years of experience working 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 5+ years Experience working in a quality role (QMS development, implementation, and/or execution) within a manufacturing environment.)-REQUIRED 2+ years of supervisory or management position - REQUIRED General Skills/Competencies Required: Strong knowledge of ISO and cGMP requirements and relevant industry standard practices. Must have ability to interpret these regulations to ensure proper implementation in the plant systems. - REQUIRED Strong knowledge of quality systems and product/process lifecycle management within a manufacturing environment - REQUIRED Proficient computer skills required including Microsoft Access, Excel and Word. - REQUIRED Digital solution development skills and understanding of systems, data integrity and data creation Leadership & communication skills: Proven ability to work well in a team environment

Created: 2024-10-19