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 Beckman Coulter Diagnostics, one of 15+ operating companies, our work saves lives--and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making--we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence.
Learn about the which makes everything possible.
The QA Specialist is responsible for leading critical quality initiatives, managing risk assessments, and implementing process improvements that drive operational excellence and cost optimization. By providing expert guidance and driving continuous improvement, the position strengthens compliance culture and scales team capabilities to meet global business priorities. The impact of this role is significant, enabling sustained compliance, proactive risk mitigation, and efficiency across strategic projects.
This position reports to the Senior Manager Quality and Regulatory Affairs and is part of the International Quality Operations located at Bengaluru, India and will be an on-site role.
In this role, you will have the opportunity to:

• Provide expert Quality and Compliance guidance for system compliance, authoring, and reviewing end-to-end design deliverables across product development and software lifecycle processes.
• Prepare and maintain documentation in alignment with regulatory requirements (FDA, ISO 13485, ISO 14971) and ensure adherence to IVDR standards.
• Collaborate with cross-functional teams to implement and uphold quality standards, driving continuous improvement in design and development processes.
• Monitor and enhance Quality Management System (QMS) performance, ensuring robust infrastructure and compliance with organizational policies.
• Lead and execute internal, supplier, and external audits, while defining and driving programs for software design quality improvement.
• Partner with Tech Ops, R&D, and global Quality & Regulatory Affairs teams to ensure alignment with organizational objectives and global quality policies.
• Communicate critical risks and quality insights to leadership, enabling proactive decision-making and strategic planning.

The essential requirements of the job include

• Bachelor's or Master's degree in Engineering, Life Sciences, or a related technical discipline.
• Extensive experience in Quality Assurance, Regulatory Affairs, or Risk Management within the medical device, diagnostics, or healthcare industry.
• Proven knowledge of global regulations including FDA, CDSCO, ISO 13485, ISO 14971, and IVDR compliance.
• Hands-on experience with Quality Management Systems (QMS), document control systems, and Software Development Life Cycle (SDLC) processes.
• Demonstrated ability to manage supplier, internal, and external audits in regulated environments.

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

• Managing global and regional regulatory submissions and compliance activities, including CDSCO, FDA, and EU requirements
• Driving large-scale continuous improvement projects such as Lean Six Sigma, statistical tools

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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Skills Required