Details:

  • Compensation: $80,000 - $100,000k
  • Benefits: Medical, Dental, Vision
  • Employment Classification: Direct Hire
  • Status: On-Site
  • Job ID: 21247
Sr Quality Engineer

Job Title: Sr Quality Engineer

Work Location: Union County, North Carolina

Summary:

Seeking an experienced Sr Quality Engineer to drive quality assurance initiatives, oversee inspection and testing protocols, and collaborate with suppliers to ensure compliance with regulatory standards in a high-volume manufacturing environment.

Responsibilities:

  • Develop and implement inspection and testing guidelines to ensure product quality and compliance with industry standards.
  • Lead corrective and preventive action (CAPA) and process improvement projects to enhance product and process quality.
  • Monitor, maintain, and improve measurement processes to comply with ISO and FDA regulations.
  • Collaborate with suppliers to investigate root causes and implement corrective actions for material or component deficiencies.
  • Audit supplier processes and establish quality requirements to ensure adherence to engineering and purchase order specifications.
  • Utilize variation management tools and techniques to mitigate supplier-related risks.
  • Design and implement methods for process control, improvement, testing, and inspection, including maintaining process flow diagrams and standardized work instructions.
  • Analyze and report supplier trends, providing management with actionable insights for continuous improvement.

Qualifications:

  • Bachelor’s degree in engineering or related field; Master’s degree preferred.
  • 3-7 years of experience in a regulated, high-volume manufacturing environment within the engineering field.
  • Proficiency in Six Sigma, lean methodologies, and quality management tools.
  • Comprehensive knowledge of statistics, statistical process control, and quality assurance principles.
  • Experience with Access Database, Excel, and complaint handling software.
  • In-depth understanding of ISO13485, ISO14971, and CFR part 820.
  • Familiarity with medical device regulations and international standards.
  • Strong computer skills, including MS Office and CAD/SolidWorks.
  • Ability to read and interpret technical drawings and documents.
  • ASQ Lead Auditor certification or equivalent auditing training.
  • Excellent communication, analytical, troubleshooting, and interpersonal skills.
  • Demonstrated ability to work independently, take initiative, and function effectively as part of a team.

Published Category: Quality & Validation

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