Staff Quality Engineer, CAPA

Looking for someone who has spent a good chunk of their career in CAPA.Position: Staff Quality Engineer, CAPALocation: San Diego, CADuration: 6+ Months ContractTotal Hours/week: 40.00If you have medical device experience that would be ideal.Trackwise is plus.Person must have managed CAPAs from beginning to closure.Key Responsibilities Will IncludeActing as the CAPA technical investigation specialist you will lead and mentor teams performing root cause analysis using appropriate techniques to conceive solutions and implementation of changes, and devise effectiveness monitoring strategiesMonitoring CAPA activities for investigations and action item implementationPerform eCAPA software administration for EtQ and TrackWiseReporting of CAPA program status, including trending CAPA metrics for actions and solutions and documenting all phases of CAPA activity in compliance with applicable standards, and procedural requirementsStaff QE maintains CAPA records in a state of audit readinessGuiding cross-functional teams assigned to product CAPAs to ensure verification and/or validation of corrective and preventive actions are effective and do not adversely affect the finished productWork with all levels of management to ensure CAPA action plans are supported and that costs/resources needed to implement the plan are availableProvide training, awareness and promote enthusiasm in the business for CAPA processMinimum RequirementsA Bachelor's Degree or higher, Engineering or Science field preferred with strong technical capability5 or more years' QA experience in medical device industry, with a solid understanding of the CAPA process and its potential to drive product quality improvementIdeal CharacteristicsThe Staff Quality Engineer should have a proven record of developing new skills quickly and cross-pollinate the takeaways from one area to anotherAbility and willingness to dig deeper, take the ownership of the issue on hand and make a meaningful contribution towards investigation and resolutionExcellent organization skills to manage many simultaneous projectsAttention to detail - Client's Staff Quality Engineers must show precision in work, especially as it relates to understanding and documenting complex quality issuesExcellent writing skills and able to summarize issues in a clear, succinct, and accurate manner that effectively conveys issues to the readerEffective interpersonal skills - Work with peers throughout the organization and be effective in engaging resourcesExcellent critical analytical skills - Ability to find root cause of why an issue occurred. Ability to review action plans and determine if the actions taken effectively address the issue#J-18808-Ljbffr