Multi-Site Sr. Plant Quality Manager - Manufacturing; Life Sciences; Beaverton, MI

Overview

Multi-Site Sr. Plant Quality Manager - Manufacturing; Life Sciences; Beaverton, MI. The role ensures the effective implementation of the Quality Management System in alignment with regulatory and corporate requirements across two manufacturing locations : Beaverton, MI and Williamsburg, MI.

Will proactively identify and report areas of concern to management while driving compliance with ISO 13485, customer specifications, and corporate quality procedures. Will be the point of contact for customer quality escalations. Will develop and implement consistent quality systems across sites to enhance operational efficiency and support strategic initiatives as guided by the BPS Quality Director. Will lead, train, and develop quality teams at multiple locations, fostering a culture of continuous improvement.

Essential Functions

• Implementation and oversight of a Quality Management System that operates in compliance with corporate quality policies and procedures, as well as relevant regulatory requirements (ISO 13485) and industry guidance.
• Oversee and manage Quality department personnel at each site, including Quality Lab, Supplier Quality, Quality Engineering, and Focus Factory Quality Engineers.
• Develop and implement consistent quality systems across all sites to enhance operational efficiency.
• Support the BPS Director of Quality in development and deployment of policies and procedures for elements of the global QMS.
• Support strategic initiatives as guided by the BPS Director of Quality.
• Promote and enforce a safe working environment, including proper use of PPE and active participation in department safety meetings.
• Investigate and report incidents while ensuring compliance with Environmental Management System (EMS) requirements and best environmental practices.
• Implement document control and review / approval of controlled documents.
• Implement ECO process including change management and review of all change controls.
• Implement supplier quality management and performance of supplier audits as appropriate.
• Manage complaint handling including robust root cause analysis and CAPA.
• Ensure robust root cause analysis investigations and CAPA for deviations and nonconforming product.
• Implement an effective Internal Audit Program.
• Ensure adequate training program is in place.
• Implement an applicable Validation Master Plan including equipment, process, product, sterilization and test methods.
• Oversee cleanroom practices including qualification, monitoring, and behavior.
• Implement Quality Risk Management in relevant aspects of the QMS.
• Maintain the Global QMS e-tool (ETQ) at the plant.
• Execute talent management activities with direct reports, including performance management, training, and development.
• Customer management including facilitating / hosting customer audits, ensuring timely and effective corrective actions to customer audit observations, reviewing / approving quality agreements, and resolving quality issues.
• Manage critical events and complaints.

IS THIS JOB FOR YOU?

TO MAKE SURE NOTHING IS FORGOTTEN

We provide unique options to fit your life through our Total Rewards Program, customizable to accommodate your needs. Options include :

A LITTLE MORE ABOUT US

Saint-Gobain's Life Sciences division solves critical problems for customers delivering life-saving medical devices, essential medications, and advanced materials. As a world-leading producer of high-performance polymer products, we aim to improve lives by making simple experiences better and supporting customers and communities worldwide.

Our culture emphasizes respect, open and honest communication, and honoring commitments. We believe that teamwork and entrepreneurship drive innovation and growth, and we provide opportunities and resources for professional development.

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

Legal Statement

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.

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