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Senior Quality Assurance Engineer

2 months ago


Irving, Texas, United States Abbott Laboratories Full time
About the Role

As a Principal Quality Assurance Engineer at Abbott Laboratories, you will play a critical role in ensuring the quality and compliance of our medical devices and diagnostic solutions. This position requires a strong background in quality assurance, regulatory compliance, and project management.

Key Responsibilities
  • Develop and maintain quality engineering methodologies and provide quality engineering support within several areas of the Quality System, including Operations, Data Analytics, and Continuous Improvement.
  • Represent the voice of Quality to lead and execute complex projects that drive continuous improvement, and ensure compliance with regulatory, customer, and internal requirements.
  • Lead, coach, and mentor junior engineers, and provide oversight to one or more QA professionals and/or contractors.
  • Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization.
  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Requirements
  • Bachelor's Degree in a relevant field, such as Engineering, Quality Assurance, or a related field.
  • Minimum 5 years of experience in Quality Assurance and/or Manufacturing and/or Engineering, with a strong background in quality assurance, regulatory compliance, and project management.
  • Industry certification or advanced degree preferred.
  • Minimum 8 years in Class III or II medical device experience, with roles of increasing responsibility, impact, and scope within a manufacturing support environment in quality.
What We Offer
  • A competitive salary range of $95,000.00 – $190,000.00, depending on location.
  • A comprehensive benefits package, including medical, dental, and vision coverage, as well as a 401(k) plan.
  • Opportunities for professional growth and development, including training and education programs.
  • A dynamic and collaborative work environment, with a team of experienced professionals.