Quality Engineer II

The Quality Engineer is responsible for supporting the implementation, maintenance, control, and monitoring of quality systems and standards that ensure the quality of materials and products at every stage of production. This role ensures compliance with corporate quality policies, regulatory requirements, ISO standards, and customer specifications/expectations. Reporting to the Quality Manager, the Quality Engineer takes a hands-on approach to support continuous improvement quality systems. These systems include receiving, in-process and final inspection, product auditing, certification, calibration, complaint handling, EVENT/CAPA/SCAR processes, nonconforming material control, product stewardship, and regulatory requests. The role will involve supporting ISO internal audits, training operators, participating in customer and registrar audits, management review, and overseeing document control. A key aspect of this role involves utilizing risk-based thinking and critical analysis to develop strategies for mitigating identified risks while maintaining business continuity. When uncertainty arises, consultation with management is required to determine the best course of action. The ability to assess strengths, weaknesses, and alternative solutions is essential for addressing challenges effectively. The Quality Engineer plays a crucial role in resolving customer requests and issues promptly while maintaining professional and tactful communication with both colleagues and customers. Regular, direct interaction with customers is required. Actively promotes a safe working environment, complies with proper use of PPE, reports incidents, and participates in functional department safety meetings.

This career position requires a Bachelor's degree - within Engineering field. ASQ certifications (e.g. CQE, CQM, CQA) and training in Six Sigma/continuous improvement/WCM methodologies are preferred. Professional experience as detailed below is also required: - 2+ years' manufacturing experience within regulated industry. - Knowledge of and experience in quality systems, such as ISO 9001, cGMP, and ISO 13485; preferred.

Saint-Gobain provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Saint-Gobain is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.