Experience:
5+ years of experience
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Employment Type:
Full time
Posted:
8/2/2017
Job Category:
Engineering
Quality Manager (m/f)
corning | Amsterdam, Missouri
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Job Description

Corning is one of the world's leading innovators in materials science. For more than 160 years, Corning has applied its unparalleled expertise in speciality glass, ceramics, and optical physics to develop products that have created new industries and transformed people's lives.

Corning succeeds through sustained investment in R&D, a unique combination of material and process innovation, and close collaboration with customers to solve tough technology challenges.

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.

 

Responsibilities:

  • Provide leadership to CBV Quality Organizations to ensure products meet both customer expectations and all applicable regulatory requirements
  • Drive Distribution Site to Quality Systems to maintain ISO 9001, ISO 13485, and 21 CRF Part 820 compliance (where applicable)
  • Process Owner and custodian of the quality& regulatory related processes
  • Improve  CBV metrics to evaluate the effectiveness of the quality system
  • Define the strategy,  priority for areas needing improvement  and drive their implementation and routine maintenance
  • Support the new product development regional launch process including supplier/customer quality issue resolution as well as local regulatory requirements
  • Interface with Division Regulatory to understand and implement and country specific product and services requirements
  • Manage the technical aspects of projects involving key customer accounts
  • Meet annual objectives of permanent quality fixes
  • Coach and develop direct employees (if applicable), define responsibilities and developmental areas
  • Interface with Global Supplier Management for local suppliers
  • Interface with EHS in Integrated Management System

 

Qualifications:

  • Bachelor’s Degree with technical discipline; any specific degree/major Science degree
  • Minimum of 3 to 5 years’ experience in Quality Assurance (preferably in supervisory role and in a medical device/pharma regulated environment)
  • Deep and/broad knowledge of ISO 9001, ISO 13485, 21 CFR Part 820, 210/211,  EU MDD and Good Distribution Practices
  • Understanding of EU environmental standards REACh, Electrical, etc
  • Familiarity with distribution processes
  • Basic understanding of Six Sigma and/or Lean systems
  • Effective project management skills; experience in managing large-scale and/or multiple projects simultaneously
  • Previous supervisory experience
  • Organized; ability to prioritize and manage multiple activities
  • 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)
  • Strong Leadership skills

 

About corning

Owens Corning is a producer of glass fiber reinforcements and other materials for composites and of residential and commercial building materials. The Company operates within two product categories: composites, which include the Composite Solutions segment and building materials, which includes its insulating systems, roofing and asphalt and other building materials and services reportable segments. The Company's products range from glass fiber used to reinforce composite materials used in transportation, electronics, marine, wind energy and other high-performance markets to insulation, roofing and manufactured stone veneer used in residential, commercial and industrial applications. On May 1, 2008, the Company sold two composite manufacturing plants in Battice, Belgium and Birkeland, Norway. (Source: 10-K)

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