Quality Engineer

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

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.