Active support in the complete lifecycle process of the medical device - starting with product definition till End of Support.
Act as an interface between SEPG team, Project Teams, and Partner’s Quality, Doc mgmt. and Process teams.
Advice projects concerning the definition and implementation of quality assurance activities Review /Approve/Author designated project documentation.
Preparation and facilitate both internal /third party/supplier audits. Defining & tracking project quality metrics and maintaining them within control limits Initiate, stimulate, and support the implementation of process improvements .Authoring Project Quality Plan in consultation with Project Manager; Perform Quality gate reviews. Ensuring compliance to QMS – SHPL/Partner. Guiding & giving trainings on QMS to all project teams. o Ensuring fulfillment of requirements throughout the project lifecycle. Authoring relevant artifacts. o Guiding teams in the Defect prevention Activities, Defect Root cause analysis.
Experience/Job Requirements: Around 4-8 years of experience in software development.
At least 3 years in quality management activities. Well versed with Agile/PI software development methodology. Excellent analytical skills with a good problem-solving attitude Excellent interpersonal, communication, collaboration and presentation skills. Familiarity with International Standards like DICOM, IEC, ISO and practices like CMMI, Hoshin Kanri, Six Sigma. Organization: Siemens Healthineers