Quality System Specialist

2 months ago

Bangalore, India Danaher Corporation Full time

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 Quality System Specialist for HemoCue is responsible for supporting the organization cross functionally in Quality System related tasks such as certification, Audits and Document Control.

This position is part of the RA/ QA organization located in India Development Center (IDC) in Bangalore and will be on-site with possibilities of flexible work. 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 Quality System (QS) Team and report to the Director Quality System at HemoCue AB in Sweden. If you thrive in a multifunctional, fast paced and supporting role and want to work to build a world-class Quality system organization—read on.

In this role, you will have the opportunity to:

  • Ensure that changes to the Quality Management System is controlled and adequately managed prior to implementation

  • Supporting organization with Quality System expertise

  • Coordinate Quality System activities related to certification and audits

The essential requirements of the job include:

  • University Degree in Science or Technology

  • 6+ years of experience from similar position 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)

  • Proficient communication skills (verbal as well as in writing) in English

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

  • Quality Audits

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.

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