Quality Engineer I - Manufacturing, Life Sciences - Akron, Ohio

Position Description

Job Summary

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.

Quality Engineer will support the Quality Manager to ensure that the Quality Management System and quality standards of the company are implemented and maintained at the Akron facility in accordance with corporate quality policies, applicable regulatory requirements, ISO requirements, and customer specifications/expectations.

Essential Functions:

• Support the development, implementation, and oversight of an effective Quality Management System that operates in compliance with corporate quality policies and procedures, and relevant regulatory requirements and industry guidance, including:
  • Change management and review of change controls
  • Investigation and CAPA management, including robust root cause analysis
  • Complaint management and performance of complaint investigations
  • Internal audit program and performance of internal audits
  • Training program; conduct training when needed
  • Preparation of Management Review materials/metrics
  • ISO certification and maintenance
• Support the oversight of product realization and commercial manufacturing activities, such as product/specification development, process capability, facilities, utilities & equipment qualification and maintenance, and materials management.
• Support the testing, review, and disposition process for production batches and incoming raw materials, including management of deviations and nonconforming product.
• Customer support, to include support of customer audits & Product stewardship requests

Required Qualifications

REQUIRED QUALIFICATIONS:

• Bachelor's Degree in a Life Sciences or Engineering discipline, Required
• 3+ years in a Regulated industry, such as life sciences, food and beverage, or aerospace with preferred emphasis in life sciences (e.g. pharma, biopharm, or medical device), Required
• 1 year in a Quality role (Quality System development, implementation, and/or execution) within a manufacturing environment, Required

Successful candidate will demonstrate:

• Good knowledge of ISO and/or cGMP requirements and relevant industry standard practices is required. Ability to interpret these regulations to ensure proper implementation in the plant systems.
• Read, interpret and draw accurate conclusions from technical or business material and data. Ability to support root cause analysis and effectively communicate necessary actions and/or recommendations.
• Responding proactively and with a sense of urgency to internal & external customer needs. Solution-focused with leadership ability to drive projects to completion.
• Ability to work well in a team environment and model to others essential behaviors, such as initiative, ownership, organizational accountability, and change management.
• Ability to support investigations and projects.

Ideal candidate will demonstrate:

• Good knowledge of quality systems and product/process lifecycle management within a manufacturing environment.
• Understanding of World Class Manufacturing (WCM) or other Continuous Improvement concepts
• Self-motivated, disciplined, and enthusiastic with high levels of drive and teamwork

Additional Description

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

Health and Wellbeing - Supporting your wellbeing, to thrive in life and work

• Medical, Prescription Drug, Vision, and Dental Insurance
• Healthcare Saving Account and Flexible Spending Account options
• LiveWell Wellness Program
• Employee Assistance Program (EAP)
• Paid Time Off and Paid Parental Leave

Retirement and Protection - Helping to make the future life you want a reality

• 401(k) with Company Match, Retirement Accumulation Plan (RAP), Cash Balance Pension Plan
• Company-provided Life Insurance, AD&D, Short-Term Disability
• Voluntary employee and dependent life insurance, Long-Term Disability, Critical Illness and Accident Insurance

Additional Benefits - Helping shape the experience and impact you want

• Commuter Benefits
• Group Legal
• Identity Theft Protection
• Auto and Home Insurance
• Pet Insurance and Discounts
• Back-up Child & Elder Care
• PerkSpot Employee Discount Program

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.

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

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.