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QA Lead Engineer

Cytiva Uppsala, Sweden Category Quality & Regulatory Affairs Job Id R1284137 Location Uppsala, Sweden
JOB DESCRIPTION

Bring more to life.

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

At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

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. Take your next step to an altogether life-changing career.

Learn about the Danaher Business System which makes everything possible.

The QA Lead Engineer maintains and improves the Quality Management System by ensuring Cytiva, Customer, and Regulatory requirements are being met through project execution and delivery of product. Quality assurance of design control, drive quality improvement from design control perspective. The role additionally supports management of quality performance targets including customer complaints, nonconformance investigations, and Field actions.

This position is part of the QA Custom Hardware department located in Uppsala, Sweden and will be onsite. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

What you will do:

  • Manage Non-conformance and CAPA processes; ensure root cause analysis and effectively implement robust action plans. Follow-up and verification of CAPAs to ensure no recurrence.
  • Be the QA link in overseeing and implementing effective design controls
  • Identify areas for improvement within the QMS and implement corrective action. Conduct internal audits and process reviews to verify.
  • Monitor QA KPIs and escalate trends and ensuring that continuous improvement activities such are raised as countermeasures.
  • Support key quality activities and be open to take on additional tasks supporting the overall performance of the QA Department

 

Who you are:

  • Bachelor’s degree preferably in a science or engineering discipline
  • A minimum of 5 years of experience in the Quality Assurance or significant experience in technical field and Life Science Industry
  • Experienced in continuous improvement methodologies & tools.
  • Good knowledge of using MS Office tools such as MS Excel to perform analytics and data management.

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

  • Comprehensive understanding of ISO 9001 requirements.
  • Strong technical knowledge of systems/devices used in the biopharma field.
  • Quality auditing

Join our winning team today. Together, we’ll 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.

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.

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