Quality Engineer II

Iatric Manufacturing Solutions produces FDA-regulated wet wipes in controlled manufacturing environments where temperature and humidity are carefully managed to minimize environmental influences on our products and ensure comfortable working conditions for our team.

Our facility is located in Morristown, Tennessee, an hour northeast of Knoxville in the foothills of the Smoky Mountains. Nestled on beautiful Cherokee Lake and midway between Bristol and Knoxville, Morristown was recently named one of the most affordable places to live by The Wall Street Cheat Sheet.

What You'll Do

As a Quality Engineer II, you will:

• Develop and execute validation protocols (IQ/OQ/PQ) for equipment, sanitation, facilities, software, and processes.
• Collaborate with customers on equipment and process validations.
• Serve as the database administrator for Infinity QS (Statistical Process Control) software.
• Provide statistical analysis support for manufacturing, new product development, trials, and validations.
• Develop SOPs related to validation and risk management.
• Monitor and prepare Key Performance Indicators (KPIs) for major customers.
• Lead Corrective Action/Preventative Action (CAPA) activities and facilitate root cause investigations.
• Train associates on quality topics such as SPC and CAPA.
• Drive continuous improvement initiatives with internal teams and external partners.

What We're Looking For

• Education & Experience:




• Bachelor's degree in Engineering, Science, or related field is required
• 3+ years of engineering experience, preferably in manufacturing.




• Technical Expertise:




• Background in nutritional products, medical devices, pharmaceuticals, or similar industries.
• Experience in FDA-regulated environments preferred.




• Skills:




• 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.

Ready to make an impact?
Join Iatric Manufacturing Solutions, where your expertise helps deliver safe, high-quality products that healthcare providers trust every day.