Quality Engineer - ISO 13485 & Validation Onsite

Energy Jobline ZR; Latrobe (Westmoreland County); On-site; USD 75,000 - 85,000; Full time

Benefits offered by this job

Health and welfare benefits including

401(k) plan

Job summary

System One is seeking a Quality Engineer in Latrobe, Pennsylvania, for a direct hire on-site role. The position focuses on maintaining the Quality Management System compliant with ISO 13485 and regulatory standards, defining product requirements, and monitoring production quality to drive improvements.

The role requires a college degree or 4+ years of QE experience, with proficiency in quality tools and data analysis.

Qualifications

• Experience using quality tools and data analysis to drive improvements.
• Background in manufacturing safety and regulatory compliance.
• College degree or 4+ years of QE experience required.

Responsibilities

• Review specifications and design documents; provide feedback to customers.
• Develop validation plans (IQ/OQ/PQ) and coordinate activities.
• Ensure validation docs meet requirements and are complete.
• Create and execute FMEAs and risk assessments as needed.
• Investigate non-conformances and implement corrective actions.
• Apply quality tools to identify improvements and solve problems.
• Support new product development to meet customer expectations.

Skills

Quality Tools

Data Analysis

Manufacturing Safety

Education

College Degree

4+ years QE experience

Tools

IQ/OQ/PQ validation

Job description

System One is seeking a Quality Engineer in Latrobe, Pennsylvania, for a direct hire on-site role. The position focuses on maintaining the Quality Management System compliant with ISO 13485 and regulatory standards, defining product requirements, and monitoring production quality to drive improvements.

The role requires a college degree or 4+ years of QE experience, with proficiency in quality tools and data analysis.