Quality Engineer

Quality Engineer II

Location : Monroe, NC 28110

Employment Type : Full-Time, Permanent

Travel Requirements : None

Role Overview

Were seeking a Quality Engineer II to support and enhance our quality systems in a regulated manufacturing environment. This role will be instrumental in ensuring compliance with ISO and FDA standards, driving continuous improvement, and supporting cross-functional initiatives.

Key Responsibilities

• Design and oversee quality control processes aligned with regulatory standards (ISO, FDA).
• Serve as the quality liaison during new product and process development, including technical drawing reviews, testing protocols, and validation activities.
• Lead root cause investigations for nonconforming materials and coordinate appropriate disposition strategies.
• Present trend analyses and nonconformance summaries to internal teams and leadership.
• Draft technical documentation for complaints, nonconformance investigations, and CAPA effectiveness.
• Conduct risk assessments (e.g., pFMEA) to support material disposition decisions via the Material Review Board.
• Apply statistical methods to evaluate testing and manufacturing processes, and lead improvement projects focused on safety, quality, and efficiency.
• Participate in change control, validation, and continuous improvement efforts within Production and Quality Control.
• Monitor and report quality trends, escalating issues as needed.
• Review and approve fixture designs and prototypes.
• Evaluate training effectiveness for inspection-related activities.
• Develop and maintain SOPs, testing procedures, validation protocols, and engineering studies.
• Ensure high accuracy and attention to detail in all tasks.
• Perform additional duties as assigned.

Qualifications :