Senior quality systems engineer, events & management controls - united states, irvine
the senior quality systems engineer, events & management controls will have the responsibilities to implement and execute global quality system elements and global electronic quality management system (eqms) at asp in compliance to all regulatory and standard requirements. the quality systems events & management control department consists of the following quality systems elements: corrective and preventive action (capa), non-conformance (nc), issue escalations, field action, data review board (drb), quality system management review (qsmr), quality planning, quality metrics, and external standard management.
under general direction and in accordance with all applicable government laws, regulations and asp policies, procedures and guidelines, this position: • responsible for implementing and executing applicable quality system processes and procedures. • monitors and maintains applicable quality system elements to ensure quality performance metrics are met. • supports cross functional team members to ensure investigations and actions are appropriately addressed and closed in a timely manner. • monitors quality data to ensure appropriate review and escalation through quality management system. • provides audit support audit readiness preparation and post audit activities. • responsible for communicating business related issues or opportunities to next management level. • contribute in quality system continuous improvement & initiatives in a cross functional environment. • performs root cause analysis, develops corrective actions and documents results in the appropriate quality system. • train others in all aspects of the applicable quality system and application of procedures • impacts a range of customer, operational, project or service activities within own team and other related teams; works within broad guidelines and policies • solves complex problems; takes a new perspective on existing solutions; exercises judgment based on the analysis of multiple sources of information • works independently, receives minimal guidance • acts as a resource for colleagues with less experience; may lead small projects with manageable risks and resource requirements
equal opportunity employer/veterans/disabled
the company will consider qualified applicants with arrest and conviction records
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