Quality Engineer (Software)

Description

Provide guidance/support to project teams for application of version control and configuration/build management practices, validation and regression testing approaches, and software related quality process improvements.Assures proper documentation of technical data generated for the assigned projects and/or tasks consistent with applicable quality directives and procedures.Documents quality systems and programs to ensure compliance with local / global regulatory requirements and corporate quality systems requirements.Participates in the following activities contributing to QMS compliance CAPA (including analysis of data and trends in complaints, nonconforming materials and root cause analysis), change control and continuous improvement, supplier quality, internal audits, quality training, etcParticipates and communicates status, business issues, and significant developments in projects.Serve as contact for assigned projects and provide coaching/mentoring for project managers and/or project team in regards to the Product Development Process (PDP) and Design Control.Certified Quality Engineering (CQE), Certified Software Quality Engineer (CSQE), Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA) desired.Software development knowledge a plus.