Quality Enginr II

A Day in the Life This role has responsibility for administrative activities supporting Software/Firmware/Hardware Issue or Defect or Anomaly Management for released products and products under development Careers that Change Lives This role has responsibility for administrative activities supporting Software/Firmware/Hardware Issue or Defect or Anomaly Management for released products and products under development. A Day in the Life An individual contributor with responsibility for maintaining administrative activities to support software/firmware/hardware issue management (enhancements, anomalies, change and documentation requests and tool specific database management). Must Have Job Responsibilities Responsibilities may include the following and other duties may be assigned Supporting software/firmware/hardware issues through released product management and design and development lifecycle while adhering to policies and procedures, using specialized knowledge and skills. Maintain tools and associated databases utilized to support software/firmware/hardware issue management and for ongoing database maintenance and tool updates. Completes reports to ensure software/firmware/hardware issue records are tracked and maintained through their perspective lifecycles Facilitates cross functional assessments and investigation, disposition, and escalation activities of software/firmware/hardware issues in conjunction with customer complaints or NPI per the applicable processes and procedures Ensures that tool and database changes are successfully implemented and maintained for software/firmware/hardware issue management of specific databases Will conduct validation activities on issue tracking tools and supporting databases Ensures software/firmware/hardware issue management complies with policies, standards, and procedures May work across a variety of software/firmware/hardware issue management lifecycle activities as determined by program needs. Database support for administration activities in assigning trainings from learning portal and assign specific tool roles to the individuals. Role may also be asked to support periodic monitoring activities associated with software issue management as we'll as post market monitoring and metrics. Development of Defect/Anomaly metrics, reports and dashboard Includes administrative management of software/firmware/hardware issues; defect or anomalies, enhancements, and change and documentation requests. Establish and lead reviews to assess and disposition software/firmware/hardware issues with a cross functional software/firmware/hardware team to investigate, complete impact and risk analysis, disposition, and determine escalation, if required. Software/firmware/hardware issues on released products will be completed in conjunction with complaint handling/complaint investigation activities. Software/Firmware issues under development will be completed with the NPI software cross functional team. Familiar and hands on experience with Defect management tools in the market like Helix, Jira, Polarion, etc Minimum Qualifications bachelors degree; Engineering, Sciences, and/or Computer Science degree preferred (eg Software Engineering, Quality Engineering, Biomedical Engineering, Computer or Life Sciences) 3-5 years of software development, or quality engineering experience in a regulated industry such as, medical devices, pharmaceutical, or biotechnology or similar technical discipline Strong bug/ anomaly handling and software/firmware/hardware issue or bug or anomaly management lifecycle experience Able to understand and follow applicable QMS processes and procedures and policies Ability to work independently once trained Strong verbal and written communication skills and ability to work in a team-oriented environment Ability to be proactive and lead initiatives Ability to self-task manage, and problem solve Ability to multitask Strongly desired: Experience with Medtronic GCH Reporting Data Familiarity with navigating Power BI Dashboards Familiarity in Jira or Perforce or similar tools to support Issue Management Tool Validation Complaint Investigation