Quality Engineer I: Validation & Process Improvement

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

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.