Quality Engineer in Latrobe

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

Job DescriptionJob Description

Job Title: Quality Engineer Location: Latrobe, Pennsylvania Type: Direct Hire Compensation: $75,000.00 - $85,000.00 Contractor Work Model: Onsite - onsite Hours: 40.0 Security Clearance: Not specified

Overview

Support the maintenance of the Quality Management System for compliance to ISO 13485 and appropriate regulatory bodies and customer agreements. Define requirements for new products, monitor production quality performance to identify opportunities for improvement, and support maintenance of quality files, procedures, and work instructions for proper adherence to the quality system.

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 is 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.

Requirements

• Manufacturing Safety
• College Degree or 4+ years QE experience
• Quality Tools and Data Analysis

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to , , , (including , childbirth, or related medical conditions), , , , , , family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

#M-1 Ref: #282-Eng Pgh