Quality Engineer II

Rockline Industries, people who make it right • Morristown, TN

6d

About The Position

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.

What You’ll Do
As a Quality Engineer II, you will:

Requirements

• Bachelor’s degree in Engineering, Science, or related field.
• 3+ years of engineering experience, preferably in manufacturing.
• Background in nutritional products, medical devices, pharmaceuticals, or similar industries.
• Experience in FDA-regulated environments.
• Experience with 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

• 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.

Benefits

• Health & Wellness: Medical, dental, vision coverage, wellness programs, and fitness reimbursement
• Financial Security: Retirement savings with company match, life and disability insurance, and optional supplemental coverage
• Career & Lifestyle: Paid time off, education reimbursement, and employee discount programs
• Mental Health Support: Confidential counseling and resources for personal and work-life needs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level