Engineer III, Quality

Company: Instrumentation Laboratory

Position: Engineer III, Quality

Location: San Diego, CA

Posted: January 15, 2021

  • Responsibilities:
  • Assist with quality planning activities to ensure design control and risk management compliance according to regulations
  • Write, review and approve validations ensuring systems, utilities and processes comply with regulations and standards; participate on validation project teams as a key resource
  • Work cross-functionally, as a key resource, to solve problems related to product or process quality issues; investigate non-conformances, identify root cause, and determine/implement appropriate corrective action plans
  • Assist with the development and implementation of statistical process controls
  • Participate, as a key resource, in design and analysis of experiments, sampling plan development and data analysis for design verification, design and process validation activities, new/existing product test methods and incoming inspection; ensure predetermined requirements are met
  • Identify and implement continual improvement activities to enhance the quality system, processes, products and standards by applying quality tools and statistical analysis
  • Participate, as a key resource, in activities that ensure products and processes comply with the requirements of the quality management system and external regulating agencies
  • Maintain the quality management system
  • Monitor product quality to ensure product compliance; work to indentify and implement improvements
  • Participate in internal and external audits
  • Create and maintain company quality documentation
  • Prepare reports as needed
  • Provide functional training to build quality awareness
  • Analyzes environmental monitoring and microbiological trends.
  • Conducts product performance and process investigations, experiments, studies, and tests related to sterility assurance and aseptic controls.
  • Prepare and present technical microbiology and sterility assurance investigative and trend reports to management
  • Formulate microbiology or sterility assurance recommendations for disposition or other actions related to product non-conformances, process deviation, product complaints investigations.
  • Assist in investigations regarding out of specifications (OOS) results, address and manage deviations related to micro procedures.
  • Provide internal environmental monitoring to support various controlled environment areas
  • Baseline water sampling, water filtration and plate counting
  • Coordinate activities for product sterilization site wide with third party vendor. Review, analyze, and maintain all records relating to sterilization.
  • Provide audit support as SME for sterilization process.
  • Lead continual improvement activities to enhance the sterilization processes and sterile products and by ensuring adherence to standards and SOP/Work Instructions are clear and accurate to users and readers.