Agilent Technologies, Inc. QA Specialist for Design Assurance of hardware in Glostrup, Denmark
We are seeking an experienced QA Specialist for Design Assurance of our Instrument.
Dako Denmark, an Agilent technologies company is looking for an experienced QA Specialist to work within cross functional reagent product development teams in an international environment.
We are looking for a candidate with excellent communication and collaboration skills that takes a pride in working with the project teams to deliver high quality products and documentation for our reagent solutions. In this role you will represent Quality Assurance in design and development projects ensuring compliance to Dako’s quality management system and external requirements in general, especially with regards to Design Control, Risk Management, Change Control, Product Verification & Validation and Process validation.
You will have a close collaboration with R&D;, RA, Operation and Clinical Affairs to assure high quality throughout the development process. You will report to the Manager of QA Design Assurance.
As a QA Hardware Specialist you will also be responsible for driving initiatives and changes to the current processes as well as collaborating with international colleagues to achieve corporate goals.
Your profile: The ideal candidate can facilitate Hardware development activities including Risk Management and has;
A background as Mechanical engineer or similar
Several (+5) years of experience working with development and Quality Assurance of InVitro Diagnostic, Medical Devices and/or Pharmaceuticals
Experience working with ISO 13485, FDA CFR 21 Part 820 and ISO14971
Proficiency in written and spoken English. Scandinavian languages is an advantage
Strong analytical skills with focus on finding the right solutions in compliance with the regulations
As a person you are energetic with drive that thrives with a high number of tasks in an inspiring environment. It is a benefit if you are persistent and master the art of negotiating.
We can offer an inspiring environment with seven skilled colleagues in the department in Glostrup. We take pride in developing new innovative solutions for the pathology labs around the world, in order to improve cancer diagnostics - and we constantly improve the quality.
Application: This is a prioritized hire so please forward your application and CV as soon as possible via our online recruitment system, we will conduct interviews on an ongoing basis.
Questions: If you have questions, please contact Hiring Manager, Brian Jensen on +45 51 67 63 81.
About Agilent: 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.
Date Posted: 17/Oct/16
Job Title: QA Specialist for Design Assurance of hardware
Business: Diagnostics and Genomics Group
Job Category: Quality/Regulatory
Job Sub-Category: Quality
Country or Area: Denmark
State/Province: Capital Region of Denmark
Shift: Day Job
Job Type: Experienced
Travel Required: Yes, 10% of the Time
Duration (Temp Positions Only): Not applicable