Corning Incorporated Quality Manager (m/f) in Amsterdam, Netherlands

Quality Manager (m/f)

Date: Aug 15, 2017

Location: Amsterdam, Netherlands, NL

Req #: 660

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