QA Specialist – Quality Management System

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 Specialist - Quality Management System (QMS) will work closely with the Change Control Process Leader and the CCQA team to drive Change Control errands across the business. In addition, the QA Specialist - QMS will play a key role in supporting other QMS processes and tasks within the wider QA department.

This position reports to the Senior Section Manager - QA Projects, and is part of the Quality Assurance department, Quality and Regulatory Affairs, located in Uppsala and will be an on-site role. 

What you will do:

• Support the organization regarding QMS related topics.
• Review and approve Change Control errands and prepare changes to the Change Control Board (CCB).
• Support the Change Control Process Leader with process improvements.
• Support other QMS Process Leaders with tasks within the QMS processes, such as assigning QMS trainings.
• Review and approve quality events related to deviations and risk assessments.
• Work closely with Change Leaders from different parts of the organization, the cross-functional team of certified Change Control QA as well as the Change Control Leader.
• Represent QA in cross-functional risk assessments.
• Attend Customer Audits to present QMS processes.
• Support key quality activities and take on additional tasks supporting the overall performance of the team.

Who you are:

• Bachelor's degree in Chemistry, Pharmacy, Engineering, or equivalent.
• Prior experience from similar QA roles within the Life Science industry managing Change Control errands, deviations and other QMS related processes.
• Knowledge of relevant quality standards and regulatory requirements (e.g., ISO 9001, ISO 13485, GMP).
• Ability to communicate effectively in Swedish and English, both written and oral.

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

• Proficient user of Microsoft Office software. Advanced skills in Excel is a plus.
• Experience of risk assessments.
• Familiarity with Lean, Six Sigma, or other process improvement methodologies.

To be successful in this role, we believe that you are a highly engaged and self-motived individual with excellent networking, interpersonal and communication skills. In addition, we're looking for a structured individual with the ability to work effectively both independently and with others. The ideal candidate should have a service-oriented mindset with quality focus and high integrity.

Interview and selection will happen continuously and the opening can be filled before the last day of application. For questions regarding the role please contact hiring manager Erika Lodén, Senior Section Manager - QA Projects, [email protected].

#LI-HJ2

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.