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QA Engineer in Nationwide India at Radiometer

Date Posted: 12/3/2018

Job Snapshot

Job Description

Job ID: IND000540

About Us

At Radiometer, our mission is to help caregivers make diagnostic decisions that save lives. To provide caregivers the insight and confidence that help them arrive at the right diagnostic decisions – decisions that in the end help save lives.
On a yearly basis millions of lives are touched by the information our solutions provide and that’s a fact, we take very seriously; the more critical the setting, the greater the requirements are and that’s why we’ve made it our vision to improve global healthcare with reliable, fast and easy patient diagnoses.
Want to know more about our mission and vision? Click on the link: Link of YouTube video
Our people
At Radiometer, we acknowledge that the information our products provide is often the difference between life and death; an acknowledgement that drives and unites us as a company. From biotech and software specialists to financial controllers and engineers, all 3200 colleagues are committed and dedicated to help realize life’s potential.

If you aspire to be part of a purpose, performance and values driven organization whose mission and vision guide every action, we are eager to hear from you.


Description

 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 crossfunctional 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 directives applicable for Medical Devices/IVD and ensure updating relevant parts of the QA system. 

 Demonstrate Danaher values and adopt DBS tools.  

Job Requirements



Qualifications

4 to 5 years of 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, Design planning. 
 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 and MDR)  Must have knowledge and experience in working with ISO 14971 and IEC 62304 
 Knowledge & experience on Agile/ Scrum SW development methodologies 


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.