Quality Engineer I: Validation, SPC & CAPA Lead

Rockline Industries, Inc.; Morristown (TN); Hybrid; USD 65,000 - 85,000; Full time

Benefits offered by this job

Health & Wellness

Financial Security

Career & Lifestyle

Mental Health Support

Job summary

Iatric Manufacturing Solutions is seeking a Quality Engineer I to support validation and quality systems at our Morristown, TN site. You will lead validation activities, analyze processes, and help ensure FDA-regulated manufacturing meets high standards.

You will collaborate with production, engineering, and suppliers to drive compliant validation plans, document master plans, and maintain validation records.

Qualifications

• Bachelor’s degree in Engineering, Science, or related field.
• 3+ years of engineering experience, preferably in manufacturing.
• Experience in FDA-regulated environments and validations.
• Strong problem-solving and root cause analysis capabilities.
• Ability to work independently and collaboratively in a fast-paced setting.
• Flexible schedule to support production and validation activities.

Responsibilities

• Facilitate and maintain validation project documentation, including the Site Validation Master Plan.
• Collaborate with customers on equipment and process validations.
• Serve as a database administrator for Infinity QS.
• Provide statistical analysis support for manufacturing, new product development, trials, and validations.
• Develop SOPs related to validation and risk management.
• Monitor and prepare KPIs for major customers.
• Lead CAPA activities and root-cause investigations.
• Train associates on quality topics such as SPC and CAPA.
• Drive continuous improvement initiatives with internal teams and external partners.

Skills

Problem solving

Root cause analysis

Independent worker

Collaborative teamwork

Flexibility schedule

Education

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

Tools

Infinity QS

Job description

Iatric Manufacturing Solutions is seeking a Quality Engineer I to support validation and quality systems at our Morristown, TN site. You will lead validation activities, analyze processes, and help ensure FDA-regulated manufacturing meets high standards.

You will collaborate with production, engineering, and suppliers to drive compliant validation plans, document master plans, and maintain validation records.