Quality Engineer II, Life Sciences, Akron, OH

Lead and/or support the oversight of product realization and commercial manufacturing activities, such as product/specification development, tech transfer, validation, 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, Including

• Support customer audits, including response and corrective action tracking
• Partner in the resolution of quality issues and customer requests by initiating effective interdepartmental communication.

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Education

Bachelor's degree in Life Sciences or Engineering - REQUIRED

License/Certification

ASQ certifications (CQE, CQM, CQA) - PREFERRED

Work Experience

• 5+ years of experience working 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
• 5+ years Experience working in a quality role (QMS development, implementation, and/or execution) within a manufacturing environment.)-REQUIRED

• 2+ years of supervisory or management position - REQUIRED

General Skills/Competencies Required

Strong knowledge of ISO and cGMP requirements and relevant industry standard practices. Must have ability to interpret these regulations to ensure proper implementation in the plant systems. - REQUIRED

Strong knowledge of quality systems and product/process lifecycle management within a manufacturing environment - REQUIRED

Proficient computer skills required including Microsoft Access, Excel and Word. - REQUIRED

Digital solution development skills and understanding of systems, data integrity and data creation

Leadership & Communication Skills

Proven 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 lead investigations and projects. - REQUIRED

A Little More About 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.

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

To make sure nothing is forgotten

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

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.