QA Design Engineer (ISO 13485, ISO 14971)

HemoCue QA Design Engineer

The conviction that “it must be possible” has been the driving force behind HemoCue for over 35 years, because when it comes to caring for people, we refuse to compromise. We take pride in being a global leader in near-patient, or point‐of‐care, testing where the patient meets the healthcare system for the first time and where accurate, reliable, and fast decisions need to be made. Our culture of positivity, engagement, and a dedication to getting it right will allow you to achieve something remarkable. Join a team where making the impossible possible has become the standard!

HemoCue 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 Design Engineer for HemoCue is responsible for ensuring high design control quality support to the R&D department during new product developments and design changes for current products.

This position is part of the RA/QA organization located in India Development Center (IDC) in Bangalore and will be located on-site with possibilities of flexibility. At HemoCue, our vision is to do things easier, to do things better, and to do them right.

You will be a part of the QA Design Team and report to the Senior QA design Specialist at IDC. If you thrive in a multifunctional, fast paced and supporting role and want to work to build a world-class Quality assurance organization—read on.

In this role, you will have the opportunity to:

• Ensure that development projects and ECOs are planned, followed and implemented according to HemoCue Quality System
• Supporting the organization with Design Control expertise
• Coordinate Quality Assurance activities related to Engineering Change Order (ECO) Process

The essential requirements of the job include:

• University Degree in Science or Technology
• 4+ years of experience from a similar role and knowledge (experience or external training) of applicable standards and regulations including but not limited to ISO 13485, Quality System Regulations for Medical Devices, and risk management for medical devices (ISO 14971)
• Knowledge on Product lifecycle
• Proficient communication skills (verbal as well as in writing) in English

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

• Medical device industry
• Software development

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.