QA Professional

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.
The position is in Bangalore and is part of a team of 5 highly skilled engineers (India team). We are supporting design control and work collaboratively with our QA colleagues for Immunoassays, Blood Gas, Transcutaneous monitoring, and IT System solutions.
The position acts as a Quality Specialist within specific projects in product development with focus on the software.
This position reports to Senior Manager, QA in India Development Center Bangalore. Responsibilities
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 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.
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 regulations applicable for Medical Devices/IVD and ensure updating relevant parts of the QA system.
Ensure that the projects and teams in IDC are Audit ready and provide support during the Internal and External audits of IDC
Provide support in driving IDC specific Quality initiatives
Demonstrate Danaher values and adopt DBS tools Requirements for this position a) Formal Education
10 years of proven 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
QA Design Control experience from the medical device or IVD industry or other similar regulated industries specifically in medical device software
In-depth knowledge of relevant standards and regulations in USA, Canada, Asia, Europe, and other key markets (FDA 21 CFR Part 820, ISO 13485, IVDR and MDR)
Must have knowledge and experience in working with ISO 14971 and IEC 62304
Knowledge & experience on Agile/ Scrum SW development methodologies
Process development and lean thinking.
Structured person with skills for planning and visual management.
Drives projects forward to reach pivotal objectives and makes things happen by following through Language
Flair & Fluency in English