QA Specialist (ISO 13485)

In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating impactful innovations like ours, doesn’t happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career.
Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
The QA Professional 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 in Bangalore and will be hybrid. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.
You will be a part of the QA Design Control team and report to the Director QA responsible for supporting design control and work collaboratively with our QA colleagues for 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:

• Provide guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment.
• Represent Quality Assurance in design and development projects and in cross-functional teams supporting new product development, agreeing and planning for requirement management and approving documentation.
• Collaborating closely with R&D, Operations and RA to assure high quality throughout the development process including design transfer and post launch activities.
• Take part in the Quality assurance activities as an active member of relevant project teams.
• Assessing overall product risk by facilitating the use of risk management tools and contributing to the risk management evaluations.

• Participating in quality training activities. 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 in IDC are Audit ready and provide support during the Internal and External audits of IDC Provide support in driving IDC 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 /MCA/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 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 specifically in medical device software
• 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, IEC 60601-1/2)
• Must have knowledge and experience in working with ISO 14971 and IEC 62304

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• Knowledge & experience on Agile/ Scrum SW development methodologies
• Process development and lean thinking.
• Structured person with skills for planning and visual management.
  

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

• Metrics planning, implementation and reporting
  

Hybrid Job Posting Language:
At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide.
At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.