Regional Quality Manager
Corning Incorporated - Lowell, MA

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Company Overview:
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

Purpose of Position:
Manage and maintain the plants’ Quality Systems and all related activities to ensure that the products, both manufactured and purchased, meet customer and all applicable regulatory requirements. Promote continuous improvement methodologies for the Quality Systems and for the Manufacturing Operations. Promote continuous improvement in customer satisfaction through inter-department communication, internal manufacturing specification understanding, sharing information, leadership of quality improvement projects

Key Responsibilities:
Manage and provide leadership to multiple CLS manufacturing Quality Organizations to ensure products meet both customer expectations and all applicable regulatory requirements. Manage plant Quality Systems to be ISO 9001, ISO 13485, and 21 CRF Part 820 compliant. Report areas for improvement to be prioritized and acted upon Management and resourcing of department project portfolio. Support the new product development process including plant resourcing, supplier/customer quality issue resolution. Drive regional department project portfolio to meet immediate and ongoing business needs including ongoing management of regional department resources. Interface with Division Regulatory to understand and implement country specific product requirements. Coach and develop direct employees in responsibilities as well as identified developmental areas. Develop methods/metrics to evaluate and continuously improve process capability and effectiveness. Manage the technical aspects of projects involving key customer accounts. Meet annual objectives of permanent quality fixes.

Required Education and Skills:
Bachelor’s Degree in a technical discipline Minimum of 10 years’ experience in Quality Assurance or Regulatory (preferably in a medical device regulated manufacturing environment) with 5 years of experience in a plant quality management role. Deep and/broad knowledge of ISO 9001, ISO 13485, 21 CFR Part 820, 210/211, and EU MDD Understanding of EU environmental standards REACH, Electrical, etc Effective project management skills; experience in managing large-scale and/or multiple projects simultaneously. Previous supervisory experience across multiple locations Organized; ability to prioritize and manage multiple activities across multiple locations. Strong Communication skills, ability to effectively communicate and interact across all levels. Flexibility; ability to work in a dynamic environment while managing multiple priorities. Tactical /analytical thinking. High sense of urgency. Proficiency in MS Office applications (EXCEL, Access), Peoplesoft, Proficy. Previous statistical / quality experience (Gage R&R, Calibration familiarity).

Desired Education and Skills:
Knowledge and familiarity of internal (and external) manufacturing specifications, process capability, quality systems, and quality architecture development. Basic understanding of Six Sigma and/or Lean manufacturing systems. Certified Six Sigma Green Belt or Black Belt. Familiarity with life sciences products and manufacturing processes. Previous measurement and/or laboratory management. ASQC (American Society of Quality Control) certification (or equivalent)

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