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Quality Engineer

3 months ago

Cardiff, Cardiff, United Kingdom Danaher Full time

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.

A Quality Engineer for Cytiva is responsible for ensuring that our Manufacturing processes are compliant to the requirements of the relevant Industry Standards and that all activities are documented correctly.

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

What you will do:

  • Provide input and support at the Cytiva Cardiff facility regarding the general requirements of ISO9001 and ISO13485. Working across the whole Cardiff organisation as part of the Quality Team and under the leadership of the QA Team Manager you will provide expertise and knowledge on the general requirements of the applicable standards.
  • Support New Product Development (NPD) Programs. Working as part of a cross functional team to ensure that any NPD program follows the Cytiva Design and Development process to meet the requirements of applicable standards.
  • Support and Provide input into Process Qualification and Validation activities. Working with Project and Process Engineering to ensure that any Transfer of Work or New Equipment/Processes are validated correctly. Reviewing and approving of Validation Plans, Protocols and Reports.
  • Participate in the Cardiff Change Control and Risk Assessment process. Preparing Impact Assessments and determining and approving Change Action Plans and Effectiveness Checks.
  • Provide input and leadership to Cytiva Cardiff Continuous Improvement Activities. Working with and leading cross functional teams in creating Continuous Improvement activities for both Quality Management System (QMS) and Production/Process activities.

Who you are:

  • Bachelor's degree in Engineering, Science Discipline or demonstrated experience in Quality Management.
  • 5 years' experience of working in the Medical Device or Life Sciences industry.
  • Demonstrated knowledge of ISO9001 and ISO13485 Quality systems
  • Strong technical aptitude (i.e. able to read & comprehend technical documentation, ability to comprehend & execute procedures, demonstrated understanding of system documentation)
  • Analytical/problem solving/root-cause analysis skills
  • Demonstrated understanding of Continuous Improvement Activities including Standard Work, 5S and Kaizen ( as examples)
  • Strong communication skills in English.

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

  • Trained ISO9001 or ISO13485 Auditor

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

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.