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Date Posted:18/Oct/16Requisition:2068386Job Title:Quality EngineerDescription:Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek –– so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.
About Dako, an Agilent Technologies Company:
Dako, based in Denmark, is a global leader in tissue-based cancer diagnostics. Hospital and research laboratories worldwide use Dako’s reagents, instruments, software and expertise to make precise diagnoses and determine the most effective treatment for cancer patients. Dako, with 1,100 employees, operates in more than 100 countries. Dako became part of Agilent Technologies on June 21, 2012. www.dako.com
We are looking for a Quality Engineer to be part of the QMS team with global responsible for ensuring that Dako's Quality Manual and Quality Management Processes are in compliance with external regulations.
- Monitor changes to applicable external quality standards.
- Act as Subject Matter Expert on updates to QMS procedures with the responsibility to ensuring alignment of the respective QMS Process with other QMS Processes and assure compliance with the regulatory requirements relevant to the business procedure in question
- Coordinates QMS updates with Process owners.
- Act as Subject Matter Expert Lead on major CAPA's and/or Change Control's
- Establish and drive procedure for assuring Quality Agreements.
- Drive changes and improvements to Quality Management Processes.
- Performing compliance gap analysis.
- Participate in Quality improvement projects.
- Develop and maintain relevant QMS procedures.
- Drive quality compliance projects and continuous improvement activities within the department and in the organization.
- Participating in the Dako Quality Training Program - developing and improving training material, conducting relevant training of new and existing employees and facilitating workshops.
- Focus on one voice within QA/RA communication in project and departments within of the organization.
-Master degree within Pharmacy, Chemical Engineering, Biology or similar is preferred.
- Experience in Quality Assurance of In Vitro Diagnostic, Medical Devices and/or pharmaceuticals.
- Knowledge of Quality System Standards and IVD/Medical Devices legislation in EU and USA.
- Experience within QMS process improvements
- Experience with Project Management
-Proficiency in written and spoken English. Fluency in Scandinavian languages is a requirement
- Strong analytical skills with focus on finding the right solutions in compliance with the regulations.
- An effective communicator at all levels, both internally and external.
- Working in a structured way with focus on deadlines.
- Team player with the ability to make independent decisions within the framework and guidelines of the organization.
- Business and result oriented and a desire to work in a dynamic and adaptable environment.
Please forward your written application and resume via our online recruitment system
• Training and development opportunities
• A commitment to work/life balance
• Total Compensation Package including medical and dental benefits, retirement programs and more
• A company with values around innovation and contribution, uncompromising integrity, trust, respect and teamwork, speed, focus, and accountability
• The diversity of cultural and individual perspectives held by our employees and their commitment to inclusion
For questions regarding this position, please call recruiter, Mads Søndergaard: +45 3695 0113
Business:Diagnostics and Genomics Group
Country or Area:State/Province:Town/City:Shift:Day Job
(Temp Positions Only):Not applicable