Senior Manager QA (Medtech)

Radiometer; Bengaluru Urban; On-site; INR 3,500,000 - 6,000,000; Full time

Job summary

You will ensure compliance with FDA, ISO 13485, ISO 14971, MDR/IVDR, contribute to risk management, traceability, and audit readiness, and mentor a skilled team to deliver safe, reliable products on time.

Qualifications

• 14–18 years of QA experience in Healthcare/Medical Devices with leadership.
• Deep knowledge of QA concepts, design control, supplier quality and global standards (FDA 21 CFR 820, ISO 13485, ISO 14971, MDR/IVDR).
• Familiarity with immunoassay principles (ELISA, chemiluminescence, lateral flow) and lifecycle for immunoassay devices.

Responsibilities

• Lead and mentor QA professionals and supervisors to achieve departmental goals.
• Guide QA activities in design and development projects ensuring compliance.
• Drive risk management, usability engineering, and audit readiness for internal and external audits.
• Collaborate with R&D, supplier quality, operations, and regulatory affairs globally.

Skills

QA leadership

Regulatory compliance

Design control

Supplier quality

Immunoassay familiarity

Education

M.Tech/B.Tech/BE in Engineering

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 Radiometer, one of Danaher’s 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. At Radiometer, life comes first. Our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. We’re a team that celebrates diverse ideas and continuous improvement. Here, you’ll find a place to grow and make a real impact, with your unique perspective driving us forward in improving patient care. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. Learn about the Danaher Business System which makes everything possible.

The Senior QA Manager for Radiometer is responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms, by partnering with R&D. Drive global quality excellence by leading design control and supplier quality initiatives that ensure safe, compliant, and innovative medical devices. This position is part of the QA Design Control team, located at BDC (Bangalore Development Center) Bangalore. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. This position reports to the Director, QA and is part of the QA Design Control team located at the Bangalore Development Center (BDC). It is an on-site leadership role responsible for guiding and mentoring team members while driving quality initiatives. As a key leader within the QA Design Control team, you will support design control and supplier quality activities, working collaboratively with QA colleagues across the globe on products related to Immunoassays, Blood Gas, Transcutaneous monitoring and IT System solutions. If you thrive in a multifunctional and an amazing role and want to work to build a world-class Quality Assurance organization—read on

In this role, you will have the opportunity to:

• Lead and Manage Teams: Oversee QA professionals and supervisors, ensuring accountability for results, effective team performance, and alignment with departmental goals.
• Drive Operational Excellence: Adapt plans and priorities to address resource constraints and operational challenges while maintaining compliance and supporting business objectives.
• Provide Technical Leadership in Design Control: Guide QA activities in design and development projects, ensuring compliance with FDA, ISO 13485, IEC 60601-1, and other global regulatory requirements.
• Champion Risk-Based Decisions and Compliance: Lead risk management processes (ISO 14971), usability engineering, requirement traceability, and audit readiness for internal and external audits.
• Collaborate Across Functions and Globally: Work closely with R&D, external partners, Supplier Quality, Operations, and Regulatory Affairs to assure quality throughout development, design transfer, and post-launch activities.
• Lead Supplier Quality Management: Drive supplier qualification, audits, compliance, and development initiatives, resolving non-conformances and ensuring continuous improvement across the supply chain.
• Represent QA Leadership and Strategic Influence: Act as a QA representative in leadership forums, influencing long-term planning, harmonizing global quality processes, and driving continuous improvement initiatives using DBS tools.

The essential requirements of the job include:

• Education: M.Tech/B.Tech/BE in Engineering (or equivalent university degree relevant to QA), with strong understanding of product design processes for multi-disciplinary products.
• Experience: 14–18 years in Quality Assurance within Healthcare/Medical Devices, including at least 3 years of people leadership experience.
• Regulatory Expertise: Deep knowledge of QA concepts, design control, supplier quality, and global regulatory standards (FDA 21 CFR 820, ISO 13485, ISO 14971, MDR, IVDR).
• Technical Knowledge: Familiarity with immunoassay principles (ELISA, chemiluminescence, lateral flow), product lifecycle for immunoassay devices (hardware/software), and system engineering concepts.
• Analytical & Process Skills: Experience with analytical performance verification, lab instrumentation, data analysis tools, and process development using lean principles.

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. Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact.