Quality Assurance Specialist

3 weeks ago


Akron, Ohio, United States Saint-Gobain Performance Plastics Full time
Quality Engineer II Job Description

We are seeking a highly skilled Quality Engineer II to join our team at Saint-Gobain Life Sciences in Akron, OH. As a Quality Engineer II, you will play a critical role in ensuring the quality of our products and services, while also contributing to the development and implementation of our quality management system.

Key Responsibilities:
  • Manage and oversee the quality management system, ensuring compliance with corporate quality policies, regulatory requirements, and industry standards.
  • Lead and support the development, implementation, and oversight of quality management processes, including document control, change management, investigation and CAPA management, complaint management, supplier quality management, internal audit program, and training program.
  • Collaborate with cross-functional teams to ensure effective product realization and commercial manufacturing activities, including 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.
  • Partner with customers to resolve quality issues and requests, and support customer audits, including response and corrective action tracking.
Requirements:
  • Bachelor's degree in Life Sciences or Engineering.
  • 5+ years of experience working in a regulated industry, such as life sciences, food and beverage, or aerospace, with a focus on life sciences.
  • 5+ years of experience working in a quality role, including QMS development, implementation, and execution, within a manufacturing environment.
  • 2+ years of supervisory or management experience.
  • Strong knowledge of ISO and cGMP requirements and relevant industry standard practices.
  • Strong leadership and communication skills, with the ability to work well in a team environment and model essential behaviors, such as initiative, ownership, organizational accountability, and change management.
What We Offer:

At Saint-Gobain, we offer a comprehensive benefits package, including medical, prescription drug, vision, and dental insurance, as well as a 401(k) with company match, retirement accumulation plan, and cash balance pension plan. We also offer paid time off, paid parental leave, and a range of additional benefits, including commuter benefits, group legal, identity theft protection, and pet insurance.

We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced quality professional looking for a new challenge, please submit your application today.



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