Quality Engineer I

Iatric; Morristown (TN); On-site; USD 70,000 - 110,000; Full time

Job summary

Iatric Manufacturing Solutions seeks an experienced engineer in Morristown, TN to lead validation activities in FDA-regulated manufacturing. You will document the Site Validation Master Plan, collaborate on equipment and process validations, and serve as the Infinity QS SPC database administrator.

The ideal candidate holds a Bachelor’s in Engineering or Science with 3+ years in manufacturing and strong CAPA/root-cause skills, SOP development, and statistical analysis.

Qualifications

• Bachelor’s degree in Engineering, Science, or related field.
• 3+ years of engineering experience, preferably in manufacturing.
• Experience in FDA-regulated environments.
• Experience with validations.
• Strong problem-solving and root cause analysis capabilities.

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 (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 KPIs for major customers.
• Lead 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.

Skills

Problem-solving

Root cause analysis

Statistical analysis

SOP development

CAPA management

Training

Education

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

Tools

Infinity QS

Job description

Morristown
Morristown, TN
328 Hamblen Ave
Morristown, TN 37813, USA

Morristown
Morristown, TN
328 Hamblen Ave
Morristown, TN 37813, USA

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

• 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 (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 Requirements:
• Bachelor’s degree in Engineering, Science, or related field.
• 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.
• Experience with validations.
• 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.

Why Join Iatric?

• Impact: Play a critical role in ensuring product safety and compliance in industries that matter.
• Culture: Work in an environment that values integrity, teamwork, and continuous improvement.
• Growth: Opportunities for professional development and leadership in a growing organization.
• Innovation: Be part of a company that invests in technology and quality to deliver best-in-class products.

Benefits at Iatric

We offer a comprehensive benefits package designed to support your health, financial security, and work-life balance, including:

• 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

Grade 10

Qualifications

Skills

Behaviors

Motivations

Education

Experience

Licenses & Certifications

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.