Quality Control Analyst

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 Cepheid, one of Danahers 15 operating companies, our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers system of continuous improvement, you help turn ideas into impact innovating at the speed of life.

At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, youll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the worlds most complex health challenges. Together, we bring MORE change to the world.

Learn about the Danaher Business System which makes everything possible.

The Quality Control Analyst is responsible for ensuring inspection process as per MDR 2017, European regulations, ISO 13485 and Cepheid corporate quality system requirements.

This position reports to the quality manager and is part of the quality and regularity compliance department located in Cepheid Manufacturing facility, Bengaluru and will be an on-site role.

In This Role, You Will Be Responsible For

• Perform inspections of incoming, in-process and finished products/stability testing and identify/troubleshoot product if non-conformance.
• Performs/monitor the laboratory equipment validation/calibration/maintenance and ensure quality control lab as per safety standards/GLP.
• Write/review SOP/WI, technical reports or documentation such as deviation reports, testing protocols, and trend analyses. Support for internal/external audit schedule, NC, CAPA for site.
  
  

The essential requirements of the job include:

• Masters degree in Biochemistry, Molecular Biology, Microbiology, Biotechnology or related discipline and a minimum of 3 years related to quality control experience.
• 2 years experience in Vitro Diagnostics (IVD) is mandate. Need to act as competent technical staff for supervision the testing / analysis of diagnostic reagents & kits.
  
  

Business Schedule Requirement

• Must be flexible to work in shift-based time schedules (able to consistently maintain schedules and meet timelines).
  
  

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

• Experience working with medical device quality systems in compliance with MDR and ISO 13485.
• Experience in leading continuous improvement efforts, in both quality systems and IVD products.
• Required strong interpersonal skills, effective communication skills / Microsoft Word and Excel knowledge / strong multi-tasking skill.
  
  

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether its a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

Join our winning team today. Together, well accelerate the real-life impact of tomorrows 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.