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Quality Engineer
Quality EngineerLHH • Monroe, NC, United States
Quality Engineer

Quality Engineer

LHH • Monroe, NC, United States
20 hours ago
Job type
  • Full-time
  • Permanent
Job description

Quality Engineer II

Location : Monroe, NC 28110

Employment Type : Full-Time, Permanent

Travel Requirements : None

Role Overview

We’re 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 :

  • Bachelor’s degree in engineering or a related discipline.
  • 2–5 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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    Quality Engineer • Monroe, NC, United States