Senior Quality Systems Engineer - Healthcare

You will manage day to day maintenance of the quality management system but also develop quality programs that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelinesProvide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure complianceWork directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulationsLead audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the auditsLead internal quality improvement activities within a quality planManage, prepare and report CAPA quality system to provide status and metrics to applicable stakeholders, both internal and externalDrive root cause investigations, provide compliant options for resolving lab technical and quality issues (lab investigation reports), in compliance with QMS and regulatory expectations.Aid in Management Review preparationAnalyze, trend, and report data supporting the quality system (KPI’s)Draft, review, and approve Quality Agreements (QAG) for equipment vendor, method developers, and service providers