Quality Engineer

Leica Microsystems

Leica Microsystems

Quality Assurance
1671 Medemblik, Netherlands · 1671 Medemblik, Netherlands · Netherlands
Posted on Friday, June 7, 2024

Be part of something altogether life-changing!

Working at Cytiva means 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.

At Cytiva you 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. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.

Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.

The Quality Engineer for Cytiva is responsible for maintaining the overview of the validated state of products, processes, methods and equipment. He / She is 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

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow’s 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.