QA Specialist I

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 QA Specialist 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. 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 BDC (Bangalore Development Center) Bangalore and will be an on-site role. You will be a part of the QA Design Control team for supporting design control activities by working collaboratively with our QA colleagues from 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:

Design Control & Product Development:

• Lead QA activities in design and development projects with a focus on Outsourced Design, ensuring compliance with FDA, ISO, and other global regulatory requirements.
• Provide expert guidance on design control elements including risk management (ISO 14971), usability engineering, requirement traceability, medical device testing (IEC
• Review and approve design documentation, verification and validation protocols, and reports.
• Participate in supplier audit at Outsourced Design Partners
• Facilitate risk assessments and contribute to risk management files.
• Support design transfer and post-market activities ensuring continuous compliance and improvement.
• Collaborating closely with R&D, external R&D partners, Supplier Quality, Operations and RA to assure high quality throughout the development process including design transfer and post launch activities.
• Mentor junior QA team members and contribute to quality training programs.
• Keep up to date knowledge of standards, regulatory requirements and regulations applicable for Medical Devices/IVD and ensure updating relevant parts of the QA system.
• Ensure that the projects and teams at BDC are Audit ready and provide support during the Internal and External audits of BDC
• Provide support in driving BDC specific Quality initiatives
• Demonstrate Danaher values and adopt DBS tools

The essential requirements of the job include:

The ideal candidate should hold a M.Tech /B.Tech/BE degree in engineering, with strength in product design processes of multi-disciplinary products. However, if the candidate has a good technical understanding and is able to learn the technical aspects in the products fast and to communicate in a technical organization, other education at university level relevant for QA work could be accepted.

• 8 to 10 years of proven experience as a quality assurance professional in a Healthcare domain
• Specialist in design control processes with experience in one or more of the following areas: Risk Management, Usability, Requirement management, systems engineering and architecture, Cybersecurity, Validation and verification.
• QA Design Control experience from the medical device or IVD industry or other similar regulated industries
• In-depth knowledge of relevant standards and regulations in USA, Canada, Asia, Europe and other key markets (FDA 21 CFR Part 820, ISO 13485, IVDR and MDR)
• Must have knowledge and experience in working with ISO 14971 and IEC
• Process development and lean thinking.
• Mentor junior QA team members and contribute to quality training programs

Radiometer, a Danaher operating 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 Danaher Benefits Info.

The annual salary range for this role is as per India. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

This job is also eligible for bonus/incentive pay.

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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