Create and execute test plans to identify defects and track defects to resolution before release to users; coordinate user testing and manage defect tracking to ensure quality application before release to production.
This position evaluates quality processes, procedures and statistical techniques, analyze production and service limitations and standards; recommend revisions of specifications when indicated; assist in the formulation of quality policies and procedures.
Identifies critical personnel, gauges, procedures, and materials needed for the completion of new products; ensures that suppliers have necessary information and facilities to deliver quality products.
The Quality Engineer, Design Control will be responsible to drive quality engineering processes and will be responsible for quality activities as part of a cross functional team that includes: R&D, Manufacturing, Production, Regulatory Affairs and other functions to drive technical decisions and project schedule.
Develop project goals and objectives to complete complex or major quality engineering projects by reviewing quality performance trends, statistical plans, cost estimates, quality plans, and conferring with management.
The individual will be responsible for driving QMS enhancement as we transition from being a clinical stage to a fully commercial operation; provide leadership and guidance during FDA or other board of health inspections.
Consult with Manufacturing, Information Management, Research Development & Engineering, Quality Assurance Operations and Product Performance Analysis teams to ensure compliance to LifeScan software development procedures and industry regulations.
The Quality Engineer Outage Services will support the Quality System needs of the Outage Services Division and provide a resource for developing and implementing good Quality practices while supporting the Divisions overall business objectives.
The QA analyst drives the quality activities of projects to deliver builds on time in order to maintain a culture of compliance with product standards. Works with department leadership to implement process adjustments as issues arise.