Quality & Technical Engineer

Quality Assurance | Santa Ana, CA

Job Function:

We are hiring for a Quality & Technical Engineer. This role is a critical position to the Quality Systems and Regulatory team. The Quality & Technical Engineer provides statistical information for quality improvement by identifying and implementing efficiencies, such as new or improvements for assay method identification, development and transfers to GMP, Stability Program, Risk Assessments of the various product and processes changes with focus on leading and driving continuous improvement with the objective to build capability within the organization to eliminate risk and improve efficiencies.

Job Duties:

  • Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes
  • Establishes statistical confidence by identifying sample size and acceptable error; determining levels of confidence
  • Establishes statistical reliability by using mean time before failure, 3-parameter distribution, reliability modeling, and reliability demonstration tests
  • Develops experiments by applying full and fractional factorial techniques as well as experience in Cell Culture company
  • Develops sampling plans by applying attribute, variable, and sequential sampling methods
  • Maintains statistical process controls by applying demerit/unit, zone charting, x2 charts for distributions and individual-medial/range for multi-stream processes
  • Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests
  • Prepares reports by collecting, analyzing, and summarizing data; making recommendations
  • Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies; maintaining American society of quality control certified quality engineer qualification
  • Provides support with the sister companies and affiliates during their process and product transfer, such as IST
  • Contributes to team effort by accomplishing related results as needed

Experience/Education:

  • BS/BA in Microbiology, Biology or Chemistry; advanced study in Microbiology is highly desirable
  • 5 or more years of biological or microbiological laboratory experience
  • Good skills in tissue culture, biochemical, and microbiological testing methodologies
  • Ability to analyze information and report research findings
  • Strong technical understanding
  • Promoting Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods and Procedures, Supports Innovation, CAD, Quality Engineering, Operations Research
  • Detailed understanding of 21 CFR Part 211, 21 CFR Part 820, ISO 13485, Canadian MDR, MDD 93/42 with emphasis on laboratory testing, material specifications, and related areas

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Principals only. No recruiters please.

FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law.

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