BD-posted 2 months ago
El Paso, TX

We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. Job Summary: The Quality Software Validation Engineer will develop and execute validations to ensure regulatory compliance to established internal and external standards related to released product or current production. The individual will support the writing of validation protocols and reports, along with the gathering and analysis of data.

  • Develop and execute validations to ensure regulatory compliance to established internal and external standards related to released product or current production.
  • Support the writing of validation protocols and reports, along with the gathering and analysis of data.
  • Collaborate across departments to support product implementation, troubleshoot issues, and maintain compliance with our quality management system.
  • Validate equipment, processes, and software to ensure they meet regulatory requirements.
  • Manage documentation systems, including equipment control and validation records.
  • Develop, review, and approve standard operating procedures (SOPs), risk assessments, and validation protocols.
  • Analyze quality metrics and identify trends to inform improvement initiatives.
  • Investigate quality issues and implement corrective actions.
  • Extract, clean, and analyze data to address product/process performance issues.
  • Lead or contribute to internal projects for new product introductions and process improvements.
  • Bachelor's degree in an engineering discipline (biomedical, mechanical, industrial, etc.).
  • A minimum of 6-10 years' software validation experience.
  • Strong experience in medical device or FDA-regulated industries, quality systems/assurance, or quality control.
  • Knowledge of FDA Quality System Regulations (QSR) and International Organization for Standardization (ISO) requirements and/or regulations.
  • Proficient in technical writing and Microsoft Office applications.
  • Experience in computer programming, graphic design, or photo editing.
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service