Quality Engineer

Danaher


Job Location:

Medemblik - Netherlands

Monthly Salary: Not Disclosed
Posted on: 20 hours ago
Vacancies: 1 Vacancy

Job Summary

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology

Youll thrive in a culture of belonging where you and your unique viewpoint matter. Andby harnessingDanahers system of continuous improvement you help turn ideas into impact innovating at the speed of life.

Working atCytivameans being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines new medicines and cell and gene therapies.

AtCytivayou will be able to continuously improve yourself and us working on challenges that truly matter with people that care for each other our customers and their patients. Take your next step to an altogether life-changing career.

The Quality Engineer for Cytiva is responsible for maintaining the overview of the validated state of products processes methods and equipment. The employee will be handling deviations of any kind. The Quality Engineer is the Quality Lead in plant wide projects. The Quality Engineer will be closely engaged in R&D projects towards introduction of new products as quality lead.

This position is part of the Quality Department located in Medemblik the Netherlands and will be on-site. At Cytiva our vision is to advance future therapeutics from discovery to delivery.

In this role you will have the opportunity to:

  • The Quality Engineer Support/lead ME/PE to implement/maintain as a team member Process flow charts Process Control Plans Process FMEA validations.
  • The Quality engineer is responsible for issuing or reviewing and approving validation documents related to gamma irradiation and product sterility claims
  • Coordinate validation activities & development of analysis methods with laboratory contractors

  • The Quality Engineer Support responses to customer questionnaires certification requests and surveys; prepare and maintain/update standard responses/data for use by Customer Service
  • The Quality Engineer is the Quality Lead in plant wide projects and will be closely engaged in R&D projects towards introduction of new products as quality lead.

The essential requirements of the job include:

  • Degree: Master in a scientific field preferable in Lifesciences (bio biomedical chemical pharma)
  • Experience: 3 years
  • Language: English (written & spoken) Dutch
  • Uses analytical mind and data analysis to creatively and pragmatically solve problems comes up with solutions
  • Knowledge of quality standards ISO 9001 and ISO 13485

It would be a plus if you also possess previous experience in:

  • Root Cause analysis
  • QMS
  • Validation processes

Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

For more information visit .


Required Experience:

IC

Bring more to life.Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnologyAtCytiva one ofDanahers15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.Youll thrive in a cu...

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