Job Title: Quality Engineer II

Work Location: Union County, North Carolina

Summary:

This position is responsible for developing, maintaining, and monitoring quality processes to ensure compliance with regulatory standards. The role involves leading investigations, authoring technical reports, supporting risk assessments, and driving continuous improvement initiatives within a regulated manufacturing environment.

Responsibilities:

• Develop and monitor quality processes to ensure compliance with ISO and FDA regulations.
• Evaluate technical drawings, test methodologies, and validations for new product and process development.
• Lead investigations into non-conformances, identify root causes, and ensure proper disposition of nonconforming products.
• Present findings from trend reviews and nonconformance investigations to teams and management.
• Author technical reports, including nonconformance and complaint investigations, CAPA effectiveness, and engineering studies.
• Conduct risk assessments such as pFMEA and participate in Material Review Board decisions for material release.
• Utilize statistical methods to identify and implement quality improvements in testing and manufacturing processes.
• Represent Quality in change control, validation, and continuous improvement activities, and monitor employee training effectiveness.

Qualifications:

• Bachelor’s degree in engineering or a related field.
• 2-5 years of experience in a high-volume regulated manufacturing environment in an engineering role.
• Experience with Six Sigma, lean methodologies, and Quality Management Tools.
• Broad knowledge of statistics and statistical process control principles.
• Proficiency with Access Database, Excel, and complaint handling software.
• Basic understanding of medical device regulations and international standards.
• Strong computer skills, including QA applications, word processing, spreadsheets, and databases.
• Ability to recognize and define problems, collect data, and draw conclusions.
• Ability to read and interpret technical drawings and documents.
• Experience with CAD/SolidWorks.
• Ability to work independently, take initiative, and function as a team player.
• Excellent communication, analytical, troubleshooting, and interpersonal skills.

Published Category: Quality & Validation