QA Professional

**Position Title**: QA Professional

**Job Location**: Bangalore, India

**Band**: P2

Opco Overview
Radiometer Medical Aps develops products and solutions that help diagnose and care for critically ill hospital patients by providing fast, accurate information on a variety of parameters. 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?

This position is for Radiometer team co-located with Beckman Coulter team at Danaher India Development Center (IDC), Bangalore.
IDC is a research and development center with the vision of accelerating product roadmaps across various Danaher business segments. Started in 2014, the center now hosts 500+ associates, for multiple Danaher operating companies focusing on Diagnostics, Life Science, and Environmental and Applied Science segments. The operating companies includes Beckman Coulter, Radiometer, Leica Biosystems, Hach, Leica Microsystems, HemoCue, Videojet, SCIEX, Cepheid, IDBS, LS, PID Digital
The IDC workforce comprises of various product engineering teams, working on development of software and hardware components of cutting-edge products for, Immunoassay, Chemistry, Hematology, Molecular diagnostics, Oncology, Neurosurgery and Water Quality. IDC has evolved as center of excellence for Cloud and data analytics, with significant contributions to the key informatics solutions. The teams consist of highly hardworking software & hardware engineers and development managers. The teams are supported by local Product managers, Quality & Regulatory and Intellectual property specialists.
The inhouse teams works in close coordination with other global R&D centers at US, France, Germany, Japan, Australia, Denmark and Sweden. Located at the center of Bangalore IT HUB, IDC is housed at state of art facility, measuring 120000 sq.ft.

**Description**:
The QA Engineering team has a significant role in ensuring safe, reliable and compliant products during new product development and maintenance of existing product platforms. This is done by collaborating, supporting, facilitating, training and communicating towards the best results by partnering with R&D.
This position is located in Bangalore. This Role requires Quality Assurance experience related to Design and Development of Medical Product Development with focus on software. To be able to guide and review all the Design Control activities and documentation of the product based on the Organizations Quality Management System.
This position also requires to perform, QA activities related to validation of Software tools in R&D. To be able to evaluate what is enough and use risk-based approach and level of necessary validation. Facilitate the SW tool validation/revalidation activities for all the Non-Product Software Validation (NPSV) and its documentation.. Knowledge of Quality management systems will enable to understand the organization processes. To be able to navigate and create results in a global environment.
This position reports to Senior Manager, QA in India Development Center Bangalore. Responsibilities
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.
Assessing overall product risk by facilitating the use of risk management tools and contributing to the risk management evaluations.
Provide Quality Assurance support in relation to SW tools validation used during design, development, operation, and maintenance of medical device products in the organization.
Collaborating closely with R&D to assure high quality and regulatory compliance in relation to SW tools validation.
Perform Review and approval of documentation related to the SW validation/revalidation activities and the design control activities related to the product.
During Design Control Quality Assurance Engineering and Software tool validation support ensure the compliance in relation to Cyber-security, 21 CFR part 11, IEC 62304, ISO 14971 and other applicable standards.
Participating in quality training activities.
Ensure that the projects and teams in Radiometer, Bangalore are Audit ready and provide support during the Internal and External audits.
Keep up to date knowledge of standards, regulatory requirements, and regulations applicable for Medical Devices/IVD.
Provide support in driving Organizational specific Quality initiatives and Demonstrates Danaher Values and adopt Danaher Business System (DBS) tools. Requirements for this position