Quality Assurance Engineer, Process Control

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Perform statistical analysis of data on CAPA reports.
• Establish a process where an in-control and out-of-control process is characterized and utilized to periodically monitor process control and act if necessary.
• Maintain rejection trending analysis and apply process capability measures.
• Afford assistance in identifying root causes and coordinate corrective action to quality issues on the packaging floor.
• Participate in equipment process and performance capability studies, including identifying characteristics, specifications and tolerances, developing sampling plans for such studies and establishing statistical control.
• Apply various statistical and problem-solving tools as part of analysis of data, issues, non-conformances or improvement opportunities.
• Knowledge in both variable and attribute control charts (frequentist statistics, along with associated knowledge of OC curves, probabilities, ARL, etc.).
• Knowledge of attribute control charts (Operating Characteristic curves, probabilities, ARL, etc.).
• Strong working knowledge in sampling standards for attributes and variables sampling plan.
• Involvement in FMEA activities and risk mitigation assessments.
• Collaborate with Quality, Engineering, Operations and other functions to support the in-process improvement initiatives.
• Understand descriptive statistics, including the appropriate use of test statistics, and distinguish between various sampling characteristics and methods of a measurement system.
• Familiarity with basic tools for quality (i. e. check sheet, control chart, pareto chart, histogram, scatter diagram).

PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE

• At least one (1) outside certification of quality engineers (i. e. American Society for Quality CQE, CSSGB, etc.) is required.
• Strong background in process control and statistical sampling techniques preferred.
• An ability to understand and apply towards Quality Engineering tasks, mathematical concepts especially as it relates to statistics and probability.
• Ability to apply mathematical operations to such tasks as frequency distribution, determination of tests, analysis, sampling, and process capabilities.
• Strong working knowledge of quality related tools, such as structured problem solving, FMEA (Failure Mode and Effects Analysis), SPC (Statistical Process Control), and DOE (Design of Experiments).
• Proficient in Microsoft Office (Word, Excel, Access, PowerPoint), Microsoft Project, Statistical Software (MiniTab).
• Background experience with medical devices, pen assembly, sterilization, vial/syringe labeling, bottling, pouching, blistering, and serialization processes.
• Strong leadership skills with the ability to challenge, influence, and build consensus.
• Must be able to analyze data and communicate issues, findings and processes and ideas in a clear, concise, technically proficient manner.