Quality Assurance Specialist 1

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 looking for Quality Assurance Specialist I to support maintaining product quality, and compliance with applicable regulatory and Quality Management System requirements, including MDR 2017 and ISO 13485. This role is responsible for batch record review and release activities, supporting nonconformance and deviation management across raw materials, components, work‑in‑progress, and finished goods.

The position works closely with cross‑functional teams on the shop floor to identify and resolve quality issues, and contribute to continuous improvement in quality systems and operational processes.

This position is part of the Quality Organization and will be based in Bengaluru.

In this role, you will have the opportunity to:

• Review and approve batch records and quality documentation to support the release of raw materials, in‑process materials, and finished goods, ensuring compliance with ISO 13485, MDR 2017, and internal quality requirements.

• Support Nonconformance, Deviation, and MRB activities, including investigation support, impact assessment, documentation, and timely closure, while reinforcing data integrity and GDP.

• Collaborate cross‑functionally with Operations, Manufacturing, Engineering, and Supply Chain through GEMBA engagement, audit participation, and proactive identification and escalation of quality, compliance, and process improvement opportunities.

Qualification:

• Master's degree in Biotechnology, Biochemistry, Pharmacy, Engineering, or a related life-science / scientific / technical field.

• 3+ years of hands‑on Quality Assurance experience within Medical Device and/or Pharmaceutical manufacturing environments.

• Experience reviewing batch records, managing nonconformances, and supporting audits within a regulated environment.

• Working knowledge of validated ERP applications, Root cause analysis & Continuous Improvement tools.

• Excellent documentation, analytical, and attention‑to‑detail skills

Preferred:

• Good skills in English language

• Ability to work independently, Flexibility to work as per production Schedule to consistently meet timelines & ability to manage multiple priorities.

Travel:

• Occasional domestic 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 .

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.

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