Quality Engineer III

The Quality Engineer III will support the Quality Manager in ensuring the Quality Management System and quality standards of the company are implemented and maintained at the facility in accordance with corporate quality policies, applicable regulatory requirements, ISO requirements, and customer specifications/expectations. The QE III will serve as a delegate to the Quality Manager. Position will lead complaint investigations, NMR investigations, Supplier Corrective Action investigations, CAPA investigations, and drive continuous improvement projects throughout the plant. Position will lead or support for Engineering Changes, Gage R&R, or validations required to support existing/new processes.

Utilize specialized technical knowledge to develop, process, and test materials used in a variety of products. Recommend materials with specific characteristics appropriate for use in a particular application. Support regulatory requirements for life sciences for internal and external requests. Ensure material compliance to meet USP Class VI, NSF, EP 3.1.0, and ISO 10993 specifications.

Conduct projects on silicone polymer processing to support manufacturing engineering, thereby building technical depth in the polymer area. Collaboratively work with R&D Group as directed by the site, participate in identifying potential projects that support manufacturing research efforts. Develop projects plans, direct and coordinates the implementation of approved plans through indirect reports. Provide personal technical input and employ strong scientific methodology in conducting projects. Respond to changing priorities as required. Identify potentially patentable development proprietary technologies resulting in patents. Integrate scientific knowledge of polymers (structure, chemistry, & properties) with knowledge of equipment & process to develop deeper understanding of silicone polymer behavior during processing. Integrate the scientific tools to explore process/material combinations for optimal processing conditions.

Job functions:

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  Support the development, implementation, and oversight of an effective QMS that operates in compliance with corporate quality polices and procedures, and relevant regulatory requirements and industry guidance, including:

  
  
  
  
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    Document control and review/approval of controlled documents

    
    
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    Change management and review of change controls

    
    
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    Investigation and CAPA management, including robust root cause analysis

    
    
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    Complaint management and performance of complaint investigations

    
    
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    Supplier quality management and performance of supplier audits as appropriate

    
    
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    Internal audit program and performance of internal audits

    
    
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    Training program

    
    
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    Implementation of Quality Risk Management in relevant aspects of the QMS

    
    
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    Management Review

    
    
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    ISO certification and maintenance

    
    
  
  
  
  
• 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.
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  Customer support:

  
  
  
  
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    Support customer audits

    
    
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    Partner in the resolution of quality issues and customer requests

    
    
  
  
  
  

• Bachelors degree in Life Sciences or Engineering required
• Minimum of five years experience in a regulated industry, such as life sciences, food and beverage, automotive or aerospace with preferred emphasis in life sciences.
• Minimum three years in a Quality role (Quality System development, implementation, and/or execution) within a manufacturing environment.
• Strong knowledge of ISO and/or cGMP requirements and relevant industry standard practices.
• Must have ability to interpret these regulations to ensure proper implementation in the plant systems.
• Demonstrated understanding of Lean Manufacturing concepts desirable.
• Must work well in a team environment, possess an ability to adapt to change in the environment, and have proven ability to exert influence in a directive and positive manner.
• Proficient computer skills required including Microsoft Word, Excel, Visio, PPT, and Project.
• Use of laboratory equipment experience. Ability to work independently. Project Management skills as well as effective coordination and communications with other departments. Demonstrated presentation skills. Knowledge of manufacturing processes. products, and product applications. The ability to work with a wide range of people. Strong in use of statistical techniques. Excellent written and oral communications skills.
• ASQ certification preferred (CQE, CQM, CQA)

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.

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
  
  
  
  

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.