Description
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.
We are looking for Lead Quality Systems to support sustained compliance, operational excellence, and scalability of the Quality Management System. This role will play a critical role in owning, standardizing, and improving site-level quality system processes, contributing to Audit readiness, compliance, operational stability, and continuous improvement, while ensuring strong alignment with global Cepheid QA policies, regulatory requirements, and Danaher Business System (DBS) principles. This role entails working closely with cross-functional teams.
This position is part of the Quality Organization and will be based in Bengaluru.
In this role, you will have the opportunity to:
+ Support & ensure compliance with India MDR, ISO 13485, IVDD/IVDR, and Cepheid Quality standards through effective prioritization, and consistent execution of Quality System activities.
+ Support Deviation & CAPA Management by applying critical systemic investigation, risks and improvement opportunities.
+ Plan, execute, and support internal audits, and support external and supplier audits, including follow‑up and verification of corrective action effectiveness.
+ Drive continuous improvement within Quality by applying Danaher Business System principles, including structured problem solving, standard work, and visual management.
+ Partner with Manufacturing, Engineering, Operations, Supply Chain, and Global Quality teams to resolve quality issues, support investigations, and integrate site practices with global systems.
Qualification:
+ Master’s degree in Biotechnology, Biochemistry, Pharmacy, Engineering, or a related life-science / scientific / technical field.
+ 9+ years of hands‑on experience within Regulated product manufacturing environments.
+ Working knowledge of ISO 13485 Quality Management Systems and relevant regulatory requirements (e.g., MDR/IVD regulations).
+ Excellent communication (both oral and written), presentation and interpersonal skills needed for cross-functional scope of role.
+ Hands-on working with validated ERP applications, leading investigations & Continuous Improvement.
Preferred:
+ ISO 13485 Lead Auditor
+ Experience in people management.
+ Ability to work independently, Flexibility & ability to manage multiple priorities.
Travel:
+ Occasional travel required (up to 10%).
Cepheid, a Danaher 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 .
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 .
Operating Company: Cepheid
