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QA Specialist with focus on Change Control

Are you interested in making a difference in the Medical Device industry?

Then we have the job for you! With reference to the Sr. QA Manager of Validation & ECO, you will join a team of highly-skilled, enthusiastic colleagues in a dynamic company. The department is QA responsible for ECO system (Change Control), validations, and projects related to cost (PPV and VAVE).

The responsibilities will be mainly QA support to the Change Control system, process validations, and projects related to changes including support of cost projects.

The job

To become successful, it's essential to have experience with QA systems, Your responsibilities and tasks will include:

  • QA system support to ECR-ECO activities
  • Participating in activities and projects related to changes
  • QA support to Process validations, in-house and at suppliers
  • To coordinate ECR-ECO activities involving our Global production sites
  • QA support to MDR/IVDR activities in relation to STED files
  • Participating in global cost projects (PPV, VAVE)
  • Participating in other internal projects in the QA function.
  • Qualifications

    "Constructive Diversity" is one of our core values, and we believe that human diversity creates a dynamic and creative environment. Therefore, we encourage diversity through our recruitment process. However, we believe that the following formal qualifications will improve your chances of success:

  • Engineering degree
  • Knowledge of the ISO 13485 and FDA legislation.
  • Proven experience with Change Control and ECO processes
  • Experience in a global environment
  • Project management experience
  • Experience with validation and verification activities
  • Proficient in both Danish and English, as documentation may be in either language. In our daily work, we speak Danish as well as English.
  • It's crucial to be passionate and committed about what you do, as well as:

  • Positive, open-minded, and proactive, adding energy to the team by taking ownership. You work well independently as well as in teams.
  • Excellent and effective communication skills, being used to working with different cultures.
  • Used to working in team projects, having multi-functional interaction.
  • Focus on targets and results. Ability to handle and prioritize many projects at the same time, keeping deadlines.
  • Good analytical skills.
  • What we offer

    An outstanding opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Denmark and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. We offer you 'freedom with responsibility, opportunities for training and career development, and a wide range of staff benefits.

    Application

    We continuously assess candidates and invite them for interviews, so please don’t hesitate to write and send in the application. For further information, please contact Sr. Manager in QA, Albert Bronstein at tel. 29131584. #LI-DA1

    Start the application process by pressing "Apply" and follow the guidelines on our corporate career site. Upload your CV and other relevant documents. We are looking forward to receiving your application.

    Interviews will be held as soon as relevant candidates have been identified

    Radiometer

    At Radiometer, we acknowledge that the information our products provide is often the difference between life and death; an acknowledgment that drives and unites us as a company. From biotech and software specialists to financial controllers and engineers, all +3800 colleagues are committed and dedicated to helping realize life’s potential. Developing on a personal and professional level is of high importance for everyone here and that is why we have many employees building and developing their careers for many years in Radiometer and Danaher.


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