**This position is located in Beaverton, Michigan.**
The Plant Quality Manager will be accountable to ensure the Quality Management System is implemented per requirements and to report areas of concern to Management. The Plant Quality Manager will be expected to ensure the plant remains in full compliance will regulatory requirements and ISO:13485 requirements as they pertain to the plant, customer specifications, and corporate quality procedures. This role will also be responsible for managing Quality department personnel at the site, including Quality Lab, Supplier Quality, and Quality Engineering.
Promotes a safe working environment, complies with proper use of PPE, reports incidents, and participates in functional department safety meetings. Exhibits good environmental practices and procedures consistent with job(s) performed and EMS (Environmental Management System) requirements.
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.
- Implementation of document control and review/approval of controlled documents.
- Implementation of ECO process including change management and review of all change controls.
- Implementation of supplier quality management and performance of supplier audits as appropriate.
- Complaint management including robust root cause analysis and CAPA.
- Ensure robust root cause analysis investigation and CAPA for deviations and nonconforming product.
- Implementation of effective Internal Audit Program.
- Ensure adequate training program is in place.
- Implementation of an applicable Validation Master Plan including equipment, process, product, sterilization and test methods.
- Implementation and oversight of quality control laboratory and review/approval of quality control testing.
- Oversight of cleanroom practices including qualification, monitoring, and behavior.
- Implementation of Quality Risk Management in relevant aspects of the QMS.
- Responsible for maintenance of the Global QMS e-tool (MQ1) at the plant.
- Support the Worldwide QMS Manager in development and deployment of policies and procedures for elements of the global QMS.
Customer Management including facilitate/host customer audits, ensure robust and effective corrective action to customer audit observations, review/approve quality agreements with customers, partner in the resolution of quality issues and requests for information by initiating effective interdepartmental communication, manage ISO certification and maintenance of certification.
Facilitate management review process including implementation of a metrics control plan to measure and monitor the health of the Quality Management System, Manufacturing System and Supply Chain.
Execute talent management activities with direct reports. Ensure proper performance management, training, and development of direct reports including:
- Quality Lab
- Quality Engineers
- Focus Factory Quality Engineers
- Supplier Quality
Bachelor's Degree required in Engineering, Supply Chain, or a Life Sciences related field (Chemistry, Biology, or Microbiology preferred).
Minimum of 8 years of experience in a regulated industry with preferred emphasis in life sciences (e.g. pharma, biopharm, or medical device) required.
Minimum of 6 years in a Quality function with at least 3 years in a Quality System design, development, and implementation role required.
At least 3 years in a direct supervisory role preferred.
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.
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 frontlines 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.
Invent yourself at Saint-Gobain Life Sciences, and together, we’ll create a better life.
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. Apply Now