Quality Engineer

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The company built on breakthroughs.
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Corning is one of the world’s leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of space, our technologies push the boundaries of what’s possible.

How do we do this? With our people. They break through limitations and expectations– not once in a career, but every day. They help move our company, and the world, forward.

At Corning, there are endless possibilities for making an impact. You can help connect the unconnected, drive the future of automobiles, transform at-home entertainment, and ensure the delivery of lifesaving medicines. And so much more.

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As a leading developer, manufacturer, and global supplier of scientific laboratory products for 100 years, Corning’s Life Sciences segment collaborates with researchers seeking new approaches to increase efficiencies, reduce costs and compress timelines in the drug discovery process. Using unique expertise in the fields of materials science, surface science, optics, biochemistry and biology, the segment provides innovative solutions that improve productivity and enable breakthrough discoveries.

Reporting directly to the Quality Manager, this position involves product team support for the manufacturing operations, provides quality guidance, product resolution decisions, and statistical problem-solving techniques to manufacturing operations and projects teams for new product introduction, process improvements, continuous improvements, and validation activities. This position works closely with other functions within the organization (Manufacturing, R&D, Continuous Improvement, Engineering, Procurement and Marketing) and is responsible for the quality of the product and process.

• Provide product team support including, Material Review Board (MRB), customer complaint activities, statistical analysis, validation support, inspection plans, metrology, quality metrics and report functions.
• Quality Help Desk and customer complaint point of contact and problem resolution including Questionnaires, Certificates and Customer Surveys, etc.
• Facilitates investigation of Nonconforming Process Report (NCPR), Situation Analysis (SA), and Health Hazar Evaluation (HHE) with clear documentation of corrective actions.
• Lead discussion on blocked stock and open notifications in Material Review Board (MRB)
• Assist with the investigation of Corrective & Preventive Actions (CAPA), non-conforming product, and customer complaints, providing solutions where possible. Communicate customer feedback to Quality Systems group.
• Apply quality engineering practices and guidance to support project teams and manufacturing operations using Six Sigma tools, FMEA, CE Diagram, DOE, MSA, Validation Protocol development, review and approval and Control Plans.
• Support Continuous Improvement activities and key plant projects.
• Develop/Revise Quality Plans including: incoming, in-process and final inspection, and provide training to those affected by the plans.
• Implement proven inspection and metrology improvements and associated training.
• Review and approve Project Design History Files.
• Create technical process documents that fit the business needs and maintain compliance to the regulatory requirements of the FDA and ISO Standards.
• Serve as a resource for performing internal audits to ensure quality system compliance.
• Able to react to change and perform other duties as assigned.

• Bachelor’s Degree in a technical discipline. (Process or Plastics Engineering preferred)
• Manufacturing quality engineering experience
• Regulated industry experience such as health care, medical device, pharmaceutical, etc).
• Green or Black belt
• Proficiency and/or working knowledge of databases and programs (i.e. SAP, EtQ, Access, Excel, Microsoft project, Minitab)

Hours of work
:

• Standard business hours;
  Monday – Friday. Flexibility required to accommodate interactions with all shifts within a 24/7 manufacturing operation.

Travel Requirements
:

• Up to 5% domestic and international
• Ability to…