BD (Becton, Dickinson and Company) Hiring for Senior Software Quality Engineer at Bengaluru, India Full Time

Job Description Summary

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.

Job Description

Responsibilities:

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:

• Design Control

• Software Lifecycle Process

• Change Control

• Risk Management

• 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

Additional Locations

Work Shift

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.