Quality Engineer

Battelle•Columbus, OH

25d•$75,000 - $95,000•Hybrid

About The Position

Battelle is seeking a Quality Engineer to serve as lead for quality assurance activities across product development and manufacturing, supporting Battelle's National Security Business Unit. A qualified individual demonstrates independent judgment and thought leadership in the execution of quality processes, proactively identifies opportunities for improvement, proposes solutions, and takes ownership of assigned projects and tasks. This role operates independently within applicable quality standards, including ISO 9001 and AS9100, and within the applicable Quality Management System (QMS). The Quality Engineer contributes to risk management, design controls, manufacturing and supplier quality, data-driven problem solving, and continuous improvement initiatives in support of high-quality products and services. This is a hybrid position reporting to the Senior Quality Manager for the business.

Requirements

Bachelor's degree in Engineering, Quality, or a related technical field and 5 years of experience in quality or engineering roles within regulated or standards-driven industries, or an equivalent combination of education and experience.
Demonstrated experience with quality systems, internal audits, design controls, risk management, CAPA, root cause analysis, statistical methods, and manufacturing and/or supplier quality.
Authorization to work in the United States.

Nice To Haves

Experience working within ISO 9001 and AS9100 environments.
Certifications such as ASQ Certified Quality Engineer or Six Sigma Green Belt.
Experience using QMS software and data analysis tools.

Responsibilities

Perform statistical analyses to support validation, process capability, investigations, and quality trend analysis; document and track nonconformances and CAPAs; and participate in root cause analysis.
Maintain the Quality Management System (QMS) in accordance with ISO 9001, AS9100, and other applicable standards, taking ownership of assigned tasks and proactively identifying opportunities for improvement.
Support quality planning activities for new product development, including design reviews, verification and validation support, and design transfer activities.
Contribute to risk management activities such as FMEA and related risk-based quality planning, taking initiative in identifying and mitigating risks.
Ensure traceability of requirements through development, testing, and release phases, and contribute to improvements in design control practices.
Partner with manufacturing teams to resolve quality issues, support incoming inspection processes and sampling plan execution, and participate in supplier qualification and performance monitoring.
Develop, maintain, and improve quality documentation, including SOPs, work instructions, records, and other controlled documents.
Ensure compliance with internal quality procedures, project requirements, and applicable regulatory and customer quality requirements.
Participate in and conduct internal audits and help prepare documentation and responses for external customer and third-party audits.
Support continuous improvement projects to enhance quality and efficiency, champion best practices and innovative approaches, and collaborate cross-functionally with engineering, manufacturing, and other stakeholders to achieve quality objectives.