Quality Engineer
State College, PA - USA
Job Summary
About the Role:
The Quality Engineer also known as QA Engineer or Manufacturing Quality Engineer is responsible for supporting and improving quality systems processes and product performance within a manufacturing environment. This role focuses on ISO 9001 compliance process validation root cause analysis and continuous improvement initiatives. The Quality Engineer works cross-functionally with engineering production and quality teams to ensure products meet specifications regulatory standards and customer expectations while driving operational excellence.
Responsibilities:
- Support and maintain the Quality Management System in compliance with ISO 9001 standards and internal quality procedures
- Perform root cause analysis and lead corrective and preventive actions using methodologies such as CAPA 8D and Fishbone analysis
- Develop and implement quality plans inspection procedures and test methods for manufactured products
- Conduct internal audits support external audits and ensure audit readiness across manufacturing operations
- Analyze quality data using statistical tools such as SPC SQC FMEA and DOE to identify trends and drive improvements
- Collaborate with manufacturing and engineering teams on process validation process capability studies and continuous improvement initiatives
- Investigate nonconformances customer complaints and supplier quality issues ensuring timely resolution
- Support design and development activities including design reviews risk assessments validation and verification processes
- Create and maintain documentation including SOPs work instructions and quality records
- Prepare reports and present quality metrics KPIs and improvement initiatives to leadership
Qualifications:
- Bachelors degree in Engineering Quality or a related technical field
- 2 to 5 years of experience in quality engineering manufacturing quality or process quality roles
- Strong knowledge of ISO 9001 standards and quality management systems
- Experience with quality tools and methodologies including SPC SQC FMEA DOE and root cause analysis
- Familiarity with ERP or MRP systems in a manufacturing environment
- Proficiency in data analysis tools Microsoft Excel and reporting software
- Strong analytical problem-solving and organizational skills
- Excellent communication skills with the ability to collaborate across cross-functional teams
- High attention to detail and ability to manage multiple priorities in a fast-paced environment
Desired Qualifications:
- Experience in advanced manufacturing electronics materials science or precision components
- Certification such as ASQ Certified Quality Engineer (CQE) or Six Sigma Green Belt
- Experience with process validation risk management and reliability engineering
- Knowledge of Lean Manufacturing and continuous improvement methodologies
- Experience supporting supplier quality management and audits
- Familiarity with regulatory standards in highly controlled or technical industries