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Quality Engineer - Nonconformity Management
Posted on 4/7/2022
San Francisco, CA, USA
Experience Level
Desired Skills
Data Analysis
  • Minimum 5 years experience in Quality Assurance/Quality Engineering
  • Bachelor's Degree, Engineering or Science field preferred, with strong technical capability
  • Experience in a clinical diagnostic laboratory, medical device or related industry leading CAPA investigations or a CAPA program
  • Working knowledge of regulations, requirements, and standards including CLIA, CAP, 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 15189 and ISO 14971
  • Demonstrated knowledge of tools and techniques required to perform detailed root cause analysis and develop thorough/complete investigations
  • Proficiency with quality tools such as flowcharts, statistical data analysis, Mathematical reasoning
  • Record of developing new skills quickly and applying the takeaways from one area to another
  • Ability and willingness to dig deeper, take ownership of the issue and make a substantial contribution toward investigation and resolution
  • Ability to handle simultaneous projects
  • Ability to summarize issues in a clear, succinct, and accurate manner that effectively conveys information to the reader
  • Work with peers throughout the organization and be effective in engaging resources
  • Ability to find root cause; ability to review action plans and determine if the actions taken effectively address the issue
  • Represent the nonconformity management process during internal, customer, and regulatory audits and inspections
  • Develop, lead and coordinate CAPA Review Board
  • Ensure CAPA action plans are robust and executed promptly, with the appropriate sense of urgency. Monitor CAPA activities for investigations and action item implementation
  • Train and mentor CAPA owners in all required elements and best practices of CAPA, including containment, root cause analysis, correction, corrective and preventive actions and effectiveness checks
  • Provide training on incident reporting, deviations and corrective actions when there is an update to the program
  • Seek and use information from other departments to determine the appropriate response to issues and regulatory impact
  • Maintain CAPA records in a state of audit readiness
  • Review all incidents to ensure proper actions are taken based on risk level
  • Perform periodic trend analysis and corrective action effectiveness measures of all quality system events and seek opportunities for improvement
  • Monitor, trend, and report nonconformity program data at Management Review meetings
  • Capture lessons learned and process weaknesses as part of daily business to continuously improve the QMS
  • Perform software administration associated with the CAPA process (Jira or other eQMS)
  • Maintain compliance with all company policies, quality systems, procedures, and applicable regulatory requirements
Invitae is a medical genetics company.
Company Overview
Invitae is a medical genetics company.