Quality Assurance Engineer, Process Control

Sharp Corporation; Allentown (Lehigh County); On-site; USD 70,000 - 100,000; Full time

Job summary

Sharp Corporation in Allentown, PA is seeking a Quality Engineer to monitor and analyze data related to Corrective Action and Preventive Action (CAPA) activities. This role requires developing and analyzing statistical data to enhance process capabilities by collaborating with various departments.

The ideal candidate will have a certification in quality engineering, strong process control skills, and experience in statistical sampling techniques. Proficiency in Microsoft Office and statistical software is essential.

Qualifications

• At least one outside certification of quality engineers is required.
• Strong background in process control and statistical sampling techniques preferred.
• Ability to apply mathematics and statistics in quality engineering tasks.

Responsibilities

• Perform statistical analysis of data on CAPA reports.
• Maintain rejection trending analysis and apply process capability measures.
• Collaborate with Quality, Engineering, and Operations to support in-process improvement initiatives.

Skills

Statistical analysis

Root cause analysis

Process control

Quality tools proficiency

Leadership skills

Education

Certification from American Society for Quality (CQE, CSSGB)

Degree in Engineering or related field

Tools

Microsoft Office Suite

Statistical Software (MiniTab)

Job description

This role is responsible for monitoring and analyzing data, trending and supporting Corrective Action and Preventive Action (CAPA) activities. It involves maintaining rejection trending analysis, analyzing trends, conducting root cause analysis, and leading corrective actions for processes and products. The position requires developing and analyzing statistical data and specifications to establish product and process capabilities. This role collaborates with several departments—including Operations, Quality, Engineering, Continuous Improvement, IT, Materials Management, and external customers—to drive process improvements and prevent repeat non‑conformances.

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 periodically monitored, acting when necessary.
• Maintain rejection trending analysis and apply process capability measures.
• Assist 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, tolerances, developing sampling plans, and establishing statistical control.
• Apply various statistical and problem‑solving tools as part of analysis of data, issues, non‑conformances, or improvement opportunities.
• Demonstrate knowledge of variable and attribute control charts, including frequentist statistics, OC curves, probabilities, ARL, and related concepts.
• Display knowledge of attribute control charts (Operating Characteristic curves, probabilities, ARL, etc.).
• Show strong working knowledge of sampling standards for attributes and variables sampling plans.
• Engage in FMEA activities and risk mitigation assessments.
• Collaborate with Quality, Engineering, Operations, and other functions to support in‑process improvement initiatives.
• Understand descriptive statistics, appropriate use of test statistics, and distinguish between various sampling characteristics and methods of a measurement system.
• Be familiar with basic quality tools such as check sheets, control charts, Pareto charts, histograms, scatter diagrams.

PREFERRED / REQUIRED EDUCATION AND/OR EXPERIENCE

• At least one outside certification of quality engineers (e.g., American Society for Quality CQE, CSSGB, etc.) is required.
• Strong background in process control and statistical sampling techniques preferred.
• Ability to understand and apply mathematics and statistics in quality engineering tasks.
• Strong working knowledge of quality‑related tools, including structured problem solving, FMEA, SPC, DOE.
• Proficiency in Microsoft Office (Word, Excel, Access, PowerPoint), Microsoft Project, and 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.
• Excellent analytical and communication skills, able to present data, findings, and ideas clearly and concisely.