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Quality Assurance Specialist

2 months ago

Charlotte, North Carolina, United States Jobot Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at Jobot. As a Quality Assurance Specialist, you will play a pivotal role in ensuring the engineering excellence that our company is known for.

Key Responsibilities
  • Develop, implement, and maintain the Quality Management System (QMS) in compliance with industry standards.
  • Oversee all aspects of the Medical Device Quality System, ensuring adherence to regulatory requirements.
  • Manage the Corrective and Preventive Action (CAPA) process, identifying areas of non-compliance and driving continuous improvement initiatives.
  • Develop and maintain Standard Operating Procedures (SOPs) for all engineering processes.
  • Manage Document Control, ensuring all documents are accurate, up-to-date, and easily accessible.
  • Conduct regular audits of the QMS, identifying any areas of risk or non-compliance.
  • Collaborate with other departments to facilitate the integration of the QMS into all areas of the organization.
  • Provide training and guidance to staff on quality assurance matters, promoting a culture of quality throughout the organization.
  • Generate comprehensive reports on the performance of the QMS, presenting findings to senior management.
  • Stay updated on industry trends, regulations, and best practices, implementing any necessary changes to the QMS.
Requirements
  • Bachelor's degree in Engineering, Quality Assurance, or a related field.
  • Minimum of 5 years of experience in a Quality Assurance role within the Engineering industry.
  • In-depth knowledge of Quality Management Systems (QMS), including development, implementation, and maintenance.
  • Proven experience with the Medical Device Quality System, CAPA, SOP, and Document Control.
  • Strong understanding of industry regulations and standards.
  • Excellent analytical and problem-solving skills, with the ability to identify areas of risk or non-compliance.
  • Strong communication skills, with the ability to explain complex concepts in a clear and concise manner.
  • Excellent organizational skills, with the ability to manage multiple tasks simultaneously.
  • Proficient in Microsoft Office Suite, particularly Excel and PowerPoint.
  • Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) will be an added advantage.