Job Description

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:

• Bachelors degree in engineering or a related discipline.
• 25 years of experience in a regulated, high-volume manufacturing setting.
• Familiarity with Six Sigma, Lean principles, and quality management tools.
• Solid understanding of statistical analysis and process control.
• Proficiency in Microsoft Access, Excel, and complaint management systems.
• Basic knowledge of medical device regulations and global standards.
• Strong computer literacy, including QA software, word processing, spreadsheets, and databases.
• Analytical mindset with the ability to identify problems, gather data, and draw conclusions.
• Ability to interpret technical drawings and documentation.
• Experience with CAD/SolidWorks.
• Self-starter with strong initiative and independence.
• Excellent communication, problem-solving, and interpersonal skills.
• Collaborative team player with the ability to work autonomously.

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