Senior Software Quality Engineer
BD
- Bangalore, Karnataka
- Permanent
- Full-time
- Responsible for being the primary quality representative for BD MMS Infusion Post Market Quality software and automation enhancements – this includes optimization of post market quality processes for existing and new product development as well as sustaining efforts.
- Responsible for creation, review and/or approval of validation documentation in support of software project administration.
- Manage all PMQ aspects of the software change control process: initiation, shaping and planning, implementation, validation (IQ, OQ and/or PQ when warranted) and Hypercare.
- Provide subject matter expertise and guidance to teams on overall software and automation systems with emphasis in process controls. Report status of software projects to designated functional leaders according to established frequencies.
- Work closely with project team members to ensure software enhancement deliverables are met.
- Works together with other Quality and Software Engineers to ensure effective administration of Post Market Quality software and automation projects.
- Monitors and ensures compliance with company policies and international standards.
- Initiates and manages Change Orders and/or Electronic Release Authorizations for new releases or design enhancements of Post Market Quality software systems.
- Identifies areas requiring quality improvement, initiates and follows through on plans of action necessary for implementation.
- Supports the development of project requirements, system hazard analysis and manages local validation activities.
- Work closely with other Software Engineers to ensure effective validation of user needs.
- Ensure that validation and project files are complete and auditable.
- Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-functional teams.