Quality Engineer I

Rockline Industries; Morristown (TN); On-site; USD 65,000 - 80,000; Full time

Job summary

Iatric Manufacturing Solutions is seeking a Quality Engineer I to support validation activities in FDA-regulated environments. You will facilitate validation docs, collaborate on equipment/process validations, and manage Infinity QS SPC data.

The role requires a Bachelor's in engineering/science, 3+ years' experience, and the ability to work independently and with cross-functional teams to drive CAPA, SOP development, and continuous improvement.

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.
• Background in SPC and CAPA is beneficial.

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, 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

Independent work

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Science

Tools

Infinity QS

Job description

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 I, you will:

• 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

• 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

Ready to make an impact?

Join Iatric Manufacturing Solutions, where your expertise helps deliver safe, high-quality products that healthcare providers trust every day.

Grade 10

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