Quality Technical Engineer
QA | Santa Ana | CA
We are seeking an individual to perform assessment for efficiencies and improvements in the quality systems departments using risk based approach and statistical techniques, that will drive continuous improvement with the objective to build capability within the organization to eliminate waste, risk and to improve efficiencies. Responsible for leading the execution of those programs and for monitoring the identified programs are working as planned and for reporting results accordingly. Some example of those programs are but not limited to; new or improvements for assay method identification, development and transfers to GMP, Stability Program, Risk Assessments of the various product and processes changes.
- Work with all cross functional departments and subsidiaries to determines quality improvement parameters throughout the entire organization.
- Determines statistical methods relevant to manufacturing processes that will improve the quality of the processes and products manufactured.
- 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, and 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.
- Contributes to team effort by accomplishing related results as needed.
- BS/BA in Microbiology, Biology or Chemistry; advanced study in Microbiology is highly desirable.
- 5 or more years of engineering, validations, 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.
- Statistical Techniques.
- Risk Assessment/Management and Failure Mode Effect Analysis (FMEA).
- 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.
- Ability to speak, write and read English well.
- Good oral and written communication skills.
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.