Quality Engineer I — Validation, SPC & CAPA

Rockline Industries, people who make it right; Morristown (TN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Health & Wellness benefits

Financial security (retirement savings

Career & lifestyle benefits

Mental health support

Job summary

Iatric Manufacturing Solutions is seeking a validated-focused engineer to manage site validation activities in a regulated manufacturing setting. You will maintain the Site Validation Master Plan, collaborate on equipment/process validations, and administer Infinity QS for SPC analyses.

The role supports manufacturing and NPD trials with emphasis on validation, risk management, and CAPA execution, while driving KPI dashboards and continuous improvement initiatives across teams.

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

Independent & collaborative work

Flexible schedule

Education

Bachelor’s degree in Engineering/Science

3+ years engineering experience

Tools

Infinity QS

Job description

Iatric Manufacturing Solutions is seeking a validated-focused engineer to manage site validation activities in a regulated manufacturing setting. You will maintain the Site Validation Master Plan, collaborate on equipment/process validations, and administer Infinity QS for SPC analyses.

The role supports manufacturing and NPD trials with emphasis on validation, risk management, and CAPA execution, while driving KPI dashboards and continuous improvement initiatives across teams.