QA Specialist – Denmark. Dako Denmark, an Agilent technologies company is looking for an experienced QA Specialist to work within cross functional instrument 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 instrument solutions.
QA Specialist – Denmark
You will have a close collaboration with R&D, RA, Operation and Service to assure high quality throughout the development process. You will report to the Manager of QA Design Assurance.
As a QA Instrument 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.
This Position Has The Responsibility For
This position is responsible for managing compliance issues and act on QA/RA initiatives to ensure overall compliance in DAKO’s QMS related processes.
This Position Has The Responsibility For
- QA handling, review and support of QMS documents
- Participate during costumer audits or regulatory inspections
- Collaborating with relevant stakeholders at site Glostrup and Carpinteria concerning performance of daily QA tasks
- Handling for Quality agreements and Questionnaires
- QA handling and approval of changes
- Drive QA compliance and QA improvement activities, when relevant e.g. procedures
- Develop and maintain implementation plan and/or quality plan, when relevant
- Keeping updated with relevant regulations and scientific knowledge within the area as well as in Agilent’s quality management system
- Improving knowledge and competences by internal on-the-job training
- Working in accordance with Agilent’s quality management system, IVD, ISO13485/MDSAP, 21CFR Part 820 (FDA)
QA Specialist. Your Profile
The ideal candidate can facilitate Reagent 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
QA Specialist. As a Person You Are
- Capable of working cross-functionally with people at all levels of the organization.
- Good cross-cultural understanding.
- Flexible, systematic and engaged team player.
- Robust with a sense of urgency combined with a good sense of humour.
- Self-motivated with a high level of engagement.
- 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.
QA Specialist. 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.
QA Specialist. Questions
If you have questions, please contact recruiter Cecilia Bengtsson, email@example.com
QA Specialist. About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a leader in life sciences, diagnostics and applied chemical markets.
The company’s 12,000 employees serve customers in more than 100 countries. www.agilent.com
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.
- Quality Assurance
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