BD (Becton, Dickinson and Company) Senior Software Quality Engineer in Bangalore, India
Job Description Summary
As directed by the Quality Manager, the Software Quality Engineer is responsible for representing the Unit Quality function regarding all activities associated with the development and implementation of medical device and non-medical products incorporating software/firmware. This person will handle projects and tasks from product inception through product launch and maintenance and play an active role in the software development processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.
Under the direction of the Quality Manager or Quality Software Lead-
Provide coordination and guidance to cross functional teams to ensure software quality objectives are met for product software, manufacturing software, quality system software, and software technologies included or used in the creation or production of medical devices
Identify software quality challenges and software quality improvement opportunities
Reviews and approves project documentation including Software Development Plans, Software Requirements Specifications, Software Design Documents, Software Test Plans/Protocols/Reports
Writes and leads risk management activities including risk management reports, software risk analysis, hazard analysis and risk management files.
Support of the following, however are not limited to:
Software Lifecycle Process
Identification of CTQ's
Manufacturing equipment Software validations/Computer system validations
Post Market Surveillance
CAPA - Root cause investigation and implementation of corrective/ preventive actions
Ensures quality conduct of projects, including design, data summary and interpretation, report preparation and review adherence to applicable regulations
Decisions, recommendations and results further the achievement of goals critical to organizational, program, or project objectives
Implements and communicates the strategic and technical direction for the product/project team
Identifies any issues that may delay product or project and recommends appropriate action to be taken
May work under consultative direction toward predetermined long-range goals and objectives
Creates and supports documentation
Serves as an extended core team member
Primary Work Location
IND Bangalore - Technology Campus
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.