Quality Assurance Engineer, Process Control

This role is responsible for monitoring and analyzing data, trending and supporting Corrective Action and Preventive Action (CAPA) activities. Responsible for maintaining rejection trending analysis. Analyze trends and collaborate to investigate trends, conduct root cause analysis and lead corrective actions for processes and products. Develop and analyze statistical data and specifications to establish product and process capabilities.
This position will work with the following departments to drive process improvements to prevent repeat non-conformances. He/She will work with Operations, Quality, Engineering, Continuous Improvement, IT, Materials Management and external customers.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
The following is a list of minimum responsibilities related to the Quality Engineer-Process Control position. Other duties may also be assigned.
- 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.
- Responsible for maintaining rejection trending analysis and apply process capability measures.
- Assists 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.
- Application of 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).

The position requires someone who has expertise and knowledge in Statistical Process Control (SPC).

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.