Sr Quality Engineer - Design Assurance
Corning Incorporated - Lowell, MA

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Job Description: Corning is the world leader in specialty glass and ceramics, creating and manufacturing keystone components that enable high-technology systems.
Corning’s history is filled with breakthrough technologies that have played an important role in the way the world works. We thrive on solving difficult, commercially relevant problems through an innovative and collaborative research and development process. Corning succeeds through sustained investment in R&D, more than 160 years of materials science and process engineering knowledge, and a distinctive collaborative culture.
Corning Life Sciences brings new and innovative laboratory tools to researchers. Our core technical competencies include polymer science, biochemistry and molecular biology, glass melting and forming, surface modification, and characterization science. As part of Corning Incorporated, we are a world leader in specialty glass and have a 150-year tradition of innovation.
We are committed to meeting customers’ unique and changing needs with original solutions for today’s emerging life sciences technologies. Our dedication to quality, technology and innovation has enabled us to produce the world’s most comprehensive line of laboratory tools for life science research. Corning Life Sciences also offers custom capabilities such as special packaging, bar coding, and printed lot numbers, to meet specific customer requirements

To know more about Corning Life Sciences, visit us at: http://www.corning.com/products_services/life_sciences.aspx

Scope of Position:
The Senior Quality Engineer – Design Assurance will be responsible for providing quality functional support for the design and development of new BD Bioscience Discovery Labware products. As a member of design and development teams you will be also responsible for ensuring new products are delivered to the market on time, within budget, and that they meet all customer and regulatory requirements. The position includes individual task responsibilities including but not limited to product and process risk assessments, validations, new supplier approval, product labeling, transfer to manufacturing, and design history file auditing.

Day to Day Responsibilities:
Primary Responsibilities:
Provide design assurance guidance and solutions for new product development projects Design Control Product and Process Validation Risk Management Coordinate activities with other quality functional areas including Regulatory and plant quality. Effectively utilizes Design for Six Sigma Methodology and tool sets Conducts and assists in vendor quality evaluation audits Working with R&D to develop quality specifications test methods and test equipment.
Hours of work/work schedule/flex-time: 40 hrs./wk.
Travel Requirements (please note if international): 10% travel

Required Education:
BA/BS in a technical or scientific discipline with college level courses in statistics. Required Years and Area of Experience: 5 -7 years experience with design assurance engineering within biotech, medical device, or pharmaceutical industries Extensive experience with product and process validations, and risk management Working knowledge of domestic and international quality and regulatory requirements Experience working in cross-functional multi location teams. Effective analytical, technical and problem solving skills. Effective oral and written communication skills, to include training and presentation skills. Willingness and ability to travel domestic and internal to BD vendors, and partner locations GMP, ISO or ASQC quality engineering certification desirable Six Sigma Methodology and Tool Set certification desirable Working knowledge of statistical methods of analysis is desirable

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Corning Incorporated is the world leader in specialty glass and ceramics. Drawing on more than 160 years of materials science and process...