Quality Engineer II

Quality Engineer II

Location: Morristown, TN
Employment Type: Full-Time, On-Site
Salary Range: $70K-$90K

Position Summary

A leading FDA-regulated manufacturing organization is seeking a Quality Engineer II to support validation, statistical process control, and continuous improvement initiatives. This role is critical for ensuring compliance, driving quality excellence, and supporting new product development in a dynamic, growth-oriented environment.

Key Responsibilities

• Develop and execute validation protocols (IQ/OQ/PQ) for equipment, sanitation, facilities, software, and processes
• Serve as administrator for SPC software, including database setup, troubleshooting, and training
• Provide statistical analysis for manufacturing, trials, and validation activities
• Draft SOPs related to validation and risk management
• Facilitate CAPA investigations, root cause analysis, and effectiveness checks
• Support continuous improvement initiatives and KPI tracking for major customers

Qualifications

• Bachelor's degree in Engineering, Science, or related field
• 3+ years of engineering experience in manufacturing (FDA-regulated environment preferred)
• Strong knowledge of validation protocols, SPC, CAPA, and quality systems
• Ability to work independently and collaboratively in a fast-paced setting
• Excellent problem-solving and communication skills

Salary & Benefits

• Competitive compensation: $70K-$90K
• Comprehensive benefits including medical, dental, vision, and 401(k)
• Paid time off and professional development opportunities
• Relocation Assistance: Provided
• Visa Sponsorship: Not available