Quality Engineer

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

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 race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, 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