Principal Quality Assurance Engineer for Medical Devices
2 weeks ago
The conviction that it must be possible has driven HemoCue for over 35 years, where we refuse to compromise in caring for people. We take pride in being a global leader in near-patient testing, making accurate and fast decisions at the patient's first healthcare encounter.
We are proud to work alongside a community of fellow Diagnostics Companies at Danaher, working together to improve patient lives with diagnostic tools addressing the world's biggest health challenges.
As a Principal Quality Assurance Engineer for HemoCue, you will ensure high design control quality support to the RD department during new product developments and design changes for current products.
This role is part of the RA/QA organization located in India Development Center (IDC) in Bangalore, with possibilities of flexibility. Our vision is to do things easier, better, and right.
You will be part of the QA Design Team and report to the Senior QA design Specialist at IDC. If you thrive in a multifunctional and fast-paced supporting role, wanting to build a world-class Quality assurance organization, read on.
In this role, you will have the opportunity to:
- Ensure development projects and ECOs are planned, followed, and implemented according to HemoCue's Quality System
- Support the organization with Design Control expertise
- Coordinate Quality Assurance activities related to Engineering Change Order (ECO) Process
To succeed in this role, you will need:
- University Degree in Science or Technology
- 4+ years of experience from a similar role and knowledge of applicable standards and regulations including 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 written) in English
A competitive salary between $80,000 - $120,000 per year is offered, considering your location and experience.
At Danaher, we bring science, technology, and operational capabilities to accelerate real-life impact. We partner with customers globally to help them solve complex challenges, architecting solutions bringing power of science to life. Our global teams pioneer what's next across Life Sciences, Diagnostics, Biotechnology, and beyond.
Join us and contribute to our diverse workforce, shaping the future of healthcare diagnostics. Lifelancer is a talent-hiring platform connecting professionals with opportunities in Life Sciences, Pharma, and IT domains.
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