QA Engineer

at  Cepheid

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.
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We are hiring a Quality Assurance Engineer to join our Validation team in Solna. As a QA Engineer in the Validation team your main responsibility is to contribute to qualification of equipment, validation of processes as well as process improvements. For this position we are looking for a self-motivated person that is willing to take on the challenge to lead global improvement projects of our processes. We expect you to be organized and paying attention to details in your work.
As QA Engineer you will represent Quality in projects related to qualifications of equipment and validation of product modifications. You will also represent QA in project core teams and review changes to manufacturing process and post-launch product changes. In addition, you will be a key player for risk assessments (FMEAs) ensuring risk management integration in the entire Life Cycle Management process.
To be successful in this role you should be able to individually plan and execute on improvement projects as well as contribute to the risk management process (FMEAs). You should be a team player with good communication skills.
We expect you to contribute to other common activities within the department which may include planning, coordination and performing common tasks, suggesting improvements and by other means actively contributing to the fulfilment of goals within our projects, department, and company.
All tasks should be performed with high quality and within timelines.
This position is onsite in Solna.

THE ESSENTIAL REQUIREMENTS OF THE JOB INCLUDE:

• Bachelor´s degree with 3+ years of related work experience OR Master´s degree with 2+ years of related work experience
• Understanding of quality systems
• Strong interpersonal, writing and communication skills, fluent in English and Swedish in written and spoken.

IT WOULD BE A PLUS IF YOU ALSO POSSESS PREVIOUS EXPERIENCE IN:

• Experience from an IVD environment and ISO13485 knowledge is a great advantage in this position.
  Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com.
  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.

• Represent Quality Assurance in project core teams and for tasks within manufacturing such as IQOQs and process changes.
• Ensure that all project deliverables/documents are executed and documented in compliance with Cepheid’s QMS and applicable regulatory requirements.
• Facilitate and/or assure Risk Management activities (FMEAs) throughout the entire Life Cycle.
• Build working relationships with cross functional teams, locally on site and globally, to ensure efficient collaboration and on-time delivery in projects,
• Work closely with Manufacturing, Regulatory Affairs, Project Management, Product Transfer, and other functions to ensure project deliverables.
• Ensure that all changes follow Cepheid´s Change Management procedures.
• Support external and internal audits as required.