Engineer III, Quality
Company: Instrumentation Laboratory
Position: Engineer III, Quality
Location: San Diego, CA
Posted: January 15, 2021
- 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.