Quality Engineer II

EPM Scientific; Morristown (TN); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Comprehensive benefits including medical, dental, vision, and 401(k)

Paid time off and professional development opportunities

Relocation Assistance

Job 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 vital for ensuring compliance and driving quality excellence in a dynamic, growth-oriented environment. Candidates should have a Bachelor's degree in Engineering or Science, along with 3+ years of relevant experience, strong knowledge of validation protocols, and excellent problem-solving skills. This position offers competitive compensation and comprehensive benefits including relocation assistance.

Qualifications

• 3+ years of engineering experience in FDA-regulated manufacturing preferred.
• Ability to work independently and collaboratively in a fast-paced setting.

Responsibilities

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

Skills

Strong knowledge of validation protocols

Statistical Process Control (SPC)

Excellent problem-solving skills

Communication skills

Education

Bachelor's degree in Engineering, Science, or related field

Job description

Overview

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