QA Associate Job in Bangalore at Danaher

Danaher is hiring for the role of QA Associate!

Responsibilities of the Candidate:

• 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.

Requirements:

• 1 to 3 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
• Knowledge on Process or Tool Validation process
• 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