Quality Engineer - Validation & Risk Analysis

Classic Industries Inc.; Latrobe (Westmoreland County); On-site; USD 55,000 - 85,000; Full time

Job summary

Classic Industries Inc. is seeking a Quality Engineer to evaluate specifications and design documents, provide feedback, and ensure validation conformance. You will develop IQ/OQ/PQ validation plans and lead risk assessments with internal and external teams.

The role requires a college degree or 4+ years of QE experience, plus skills in quality tools and data analysis. You will support root-cause investigations and drive improvements in product quality.

Qualifications

• College degree or 4+ years QE experience.
• Experience with quality tools and data analysis.

Responsibilities

• Evaluate specification, requirements, and design documents to provide prompt and valuable feedback to internal and external customers.
• Develop detailed and well-structured validation plans using IQ OQ PQ structure.
• Estimate, prioritize, plan and coordinate validation activities to ensure conformance to regulations, internal requirements and customer requirements.
• Ensure all validation documentation completed per requirements.
• Develop and execute FMEAs and risk assessments with internal and external teams as needed.
• Support investigation of root cause of non-conformances and corrective actions.
• Use quality tools to analyze and identify areas for improvements and problem solving techniques.
• Support new product development and production to ensure that the product meets customer expectations.

Skills

Quality Tools

Data Analysis

Education

College Degree or 4+ years QE experience

Job description

Classic Industries Inc. is seeking a Quality Engineer to evaluate specifications and design documents, provide feedback, and ensure validation conformance. You will develop IQ/OQ/PQ validation plans and lead risk assessments with internal and external teams.

The role requires a college degree or 4+ years of QE experience, plus skills in quality tools and data analysis. You will support root-cause investigations and drive improvements in product quality.