Quality Engineer - Manufacturing - Life Sciences

Position Description

Job Summary

If you want to 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.

As the Quality Engineer you will support and lead the site Quality Department to compliance with regulatory, customer, local/site, and corporate requirements in accordance with the ISO 9001. You will understand the diverse compliance expectations and obligations for which the site is responsible, assess for gaps, and independently gather the necessary information to address those gaps. In addition, you will provide direct internal and external responses regarding product stewardship requests and are responsible for the environmental monitoring controls to maintain an ISO 7 certified clean room manufacturing area.

The essential functions of the position are, but not limited to, the following:

• Ensure quality compliance of products manufactured onsite an/or by a third-party subcontractor
• Engage suppliers and subcontractors
• Create professional memo letters as formal responses to inquiries.
• Maintain register of compliance documents and file management of supporting evidence
• Single point accountability for product stewardship requests including QMS questionnaires, intercompany and customer inquiries, documentation submissions and other requests
• Coordinate environmental monitoring activities, receiving and reviewing test reports, documenting and trending results
• Review and oversight of site operational compliance to specific requirements such as FDA, NSF, EU for food contact, medical and pharma application

Required Qualifications

• Bachelor's degree in Engineering/Mathematics or Related Sciences
• 3 years of regulatory compliance in a Manufacturing Environment
• 5 years of quality engineering function in a Manufacturing Environment

PREFERRED:

• 2 years of Internal Auditing
• 2 years of ISO 9001: 2015 Certified Training
• 3 years of Lean Manufacturing experience

Additional Description

Benefits Include, but are not limited to:

• Medical, Dental and Vision benefits
• Company Paid Short-term Disability
• 11 Paid Holidays per year
• 15 vacation days per year
• 401(k) Company Match
• Pension Program
• Employee Stock Purchase Option

Company Summary

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.

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.

Quality Engineer - Manufacturing - Life Sciences

Location: Mickleton, New Jersey

Posting Date: 03/16/2023

Job Code: USA04705