Job Information
Danaher Corporation Sr QA Scientist in Solna, Sweden
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.
Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.
Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.
As a Sr. QA Specialist you will represent Quality in new product development teams with the primary responsibility to quality assure the Design Control process and to lead risk management activities, ensuring risk management integration in the entire development process. You may also support post-launch activities such as product design changes or market expansion projects by assuring change control, including the assessment of changes to product claims.
The responsibility of a Sr QA Specialist also includes the maintenance and improvement of QMS compliance and effectiveness through continuous improvements and updates in response to regulatory changes.
The qualified candidate will be able to demonstrate leadership capability and skills necessary to drive continuous improvements and provide consultation and support to the organization to achieve compliant and effective processes.
This position is part of the Quality department and will be located in Solna, Stockholm, Sweden.
In this role, you will have the opportunity to:
Represent Quality Assurance in project core teams and provide guidance and decisions to the cross-functional teams with focus on Design Control to ensure compliance with internal procedures and applicable ISO and FDA requirements.
Build working relationships with cross functional teams including R&D, Product Transfer, Program Management, Marketing, Regulatory Affairs, Clinical Affairs and others to ensure efficient collaboration and on-time delivery of new products to the market
Ensure that all project deliverables are executed and documented in compliance with Cepheid’s Quality Management System and applicable regulatory requirements
Facilitate and/or assure performing Risk Management activities throughout the entire Product Life Cycle
Work closely with R&D, Marketing, Regulatory Affairs and others to ensure that product requirements and design output meet the intended use and user needs and that Design Reviews are continuously held and documented according to established procedures
Provide guidance to junior team members on design control best practices and interpretation of internal processes and regulatory requirements
Collaborate with Quality Systems and Regulatory Affairs to ensure that established design control procedures in Cepheid’s Quality Management System are compliant with all relevant regulatory requirements and are updated in response to changes
Support internal and external audits as Subject Matter Expert for Design Controls for assay projects
The essential requirements of the job include:
University’s degree within Molecular Biology, Applied Sciences, Biotechnology or Biomedical Engineering
Minimum 5 years of relevant experience in Quality working with development of IVD tests, or similar experience from related areas
Experience from implementing design control and leading risk management activities in medical device/diagnostic industry
Strong understanding of quality systems methodology and applications
Demonstrated knowledge of domestic and international quality systems and other standards such as FDA QSR, IVDR, ISO 13485 and ISO 14971
Possess excellent analytical and troubleshooting skills, must be self-motivated, willing to learn new concepts, technologies and products
Have strong interpersonal, writing and communication skills; fluent English in written and spoken; Swedish is an advantage
Wants to work in a fast-paced environment with and manage continuous changes and improvements
Dedication to product quality and customer satisfaction
Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals
It would be a plus if you also possess previous experience in:
Demonstrated knowledge in Molecular Biology and/or Virology or similar with understanding of relevant aspects for PCR based molecular tests.
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.
Operating Company: Cepheid