Quality Engineer I - Validation, CAPA & SPC Expert

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 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.