Arbetsbeskrivning

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 which makes everything possible.

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.

In this role, you will have the opportunity to:

• Represent Quality Assurance in project core teams and for tasks within manufacturing such as IQOQs and process changes.
• Build working relationships with cross functional teams including Manufacturing, Technical Operations, R&D, Product Transfer, Program Management, and others to ensure efficient collaboration and on time delivery
• Review and approve product and project documentation, including validations, for compliance towards Cepheid’s Quality Management System and relevant regulatory requirements
• Facilitate and/or assure performance of Risk Management activities post launch
• Identify and implement changes and process improvements to the QA Organization
• Support during internal or external audits and inspections

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 in English

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

• Working in a controlled environment such as working according to ISO13485/IVDR or similar knowledge is a great advantage in this position.
• Manufacturing operations and GDP

Significant emphasis will be placed on the candidate's personal fit for the 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.