At Cepheid we are passionate about improving health care through rapid 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 The Senior Manager Quality Systems is responsible evaluating and improving the Quality Management System by employing best practices to ensure compliance to applicable Medical Device and IVD regulations standards and Danaher Policies This role has the opportunity to work with other Cepheid sites around the world to build a world-class Global Quality Management System This position is part of the Quality department and will be located in Bengaluru India The Quality department collaborates with cross-functional business partners to ensure that customer needs and safety are met government regulations and quality requirements are effectively monitored measured maintained and continuously improved In this role you will have the opportunity to Manage the Indian Development Center IDC Internal Audit program to schedule execute and document audits in compliance with Cepheid Policy and procedures ensuring timely closure of findings with corrective actions Manage external regulatory audits by organizing pre-audit logistics hosting audits and directing post-audit corrective action implementation Implement and maintain global document control processes aligned with FDA Quality System Regulation QSR ISO 13485 and other applicable regulatory standards Administer and maintain the Quality System Training application Compliance Wire ensuring accurate configuration user access and training completion tracking Monitor and ensure compliance with FDA regulations European Union In Vitro Diagnostic Regulation IVDR and other global regulatory requirements applicable to medical devices and diagnostics Maintain audit records document control logs and training system data to provide measurable compliance evidence during inspections and regulatory reviews Coordinate cross-functional regulatory readiness activities to ensure systems documentation and training platforms meet audit and inspection requirements The essential requirements of the job include Bachelor s degree in a scientific or engineering discipline with 9 years of industry experience OR Master s degree with 7 years of industry experience Minimum 2 years of leadership experience in regulated medical device diagnostics or life sciences environments Proficiency with FDA Quality System Regulation QSR ISO 13485 and EU IVDR compliance frameworks Demonstrated experience implementing and maintaining domestic and international quality management systems Direct involvement with regulatory audits inspections and certification processes in FDA- and ISO-regulated industries Hands-on experience with electronic quality management systems eQMS or document control platforms used in regulated environments Ability to travel up to 10 for audits inspections or operational support It would be a plus if you also possess Certified Quality Auditor CQA or ISO 13485 Lead Assessor certification 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

📌 Senior Manager, Quality Systems (Karnataka)
🏢 Cepheid
📍 Karnataka