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
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