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's innovations touch almost every major industry around the world. Within its Life Sciences division, teams are solving critical problems for customers who are getting life-saving medical devices to the front lines 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.

- Join Us at Saint-Gobain Life Sciences. Together, we'll create a better life.

- to Explore more opportunities within Saint-Gobain Life Sciences.

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.

Applicants for roles based in Washington state or remote roles that would be worked from Washington state are encouraged to direct any concerns regarding the state's Pay Transparency laws to the SGNA HR Compliance team at  SGNA_H .

At Saint-Gobain, our goal is to deliver a comprehensive Total Rewards package to support your well-being and improve daily life for you and your family. We value your contribution to our purpose, Making the World a Better Home, and your Total Rewards package aims to help you plan for the future you want.

- Employees have the flexibility to choose the benefits that best fit their individual needs:

- - Health and Wellbeing -…