Quality Engineer – ISO 13485 Onsite (Latrobe)

System One, Inc.; Latrobe (Westmoreland County); On-site; USD 75,000 - 85,000; Full time

Job summary

System One, Inc. seeks a Quality Engineer for onsite work in Latrobe, Pennsylvania. The role supports the Quality Management System, ISO 13485 compliance, and regulatory/customer requirements.

You will define product requirements, monitor quality performance, and maintain quality files, procedures, and work instructions. Responsibilities include evaluating specs and designs, planning validation activities (IQ/OQ/PQ), conducting risk assessments, and driving root-cause investigations.

Qualifications

• Bachelor's degree or 4+ years QE experience.
• ISO 13485 / regulatory compliance familiarity helpful.
• Proficient with quality tools and data analysis.

Responsibilities

• Evaluate specifications, requirements and design docs to provide feedback to customers.
• Develop validation plans (IQ/OQ/PQ) and coordinate validation activities.
• Ensure validation documentation is completed per requirements.
• Develop and execute FMEAs and risk assessments with teams.
• Investigate root causes of non-conformances and implement corrective actions.
• Use quality tools to analyze data and identify improvements.
• Support new product development and production to meet customer expectations.

Education

College Degree or 4+ years QE experience

Tools

Quality Tools

Data Analysis

Job description

System One, Inc. seeks a Quality Engineer for onsite work in Latrobe, Pennsylvania. The role supports the Quality Management System, ISO 13485 compliance, and regulatory/customer requirements.

You will define product requirements, monitor quality performance, and maintain quality files, procedures, and work instructions. Responsibilities include evaluating specs and designs, planning validation activities (IQ/OQ/PQ), conducting risk assessments, and driving root-cause investigations.