Quality Engineer II - Validation

BD-posted 9 months ago
Mid Level
Grayson, GA
Miscellaneous Manufacturing
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The Quality Engineer II is responsible for validation of new processes or process improvement, identifying critical parameters, experimentation to verify optimum setting or configurations, resolving problems with equipment and processes, and the site calibration program. 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.

  • Ensure compliance with regulatory requirements for both domestic and international markets; participates in U.S. FDA inspections as required.
  • Participate in multi-functional teams responsible for developing and implementing robust quality assurance systems.
  • Apply statistical techniques and other problem solving methods to identify root causes and implement effective corrective actions.
  • Lead investigations related to product complaints, customer notifications, and nonconformances.
  • Develop test methods, specifications, and other technical documents.
  • Maintain quality records and documentation including CAPAs, audit findings, training, and investigation reports.
  • Provide guidance and training to production personnel on quality issues.
  • Review and approve process changes (PCN) prior to implementation ensuring the impact on product quality and safety is understood and controlled.
  • Monitor key performance indicators and metrics reporting results to management.
  • Represent Quality department on new product development projects.
  • Bachelor's degree or equivalent experience + education.
  • Master's degree preferred.
  • Minimum of 2-3 years relevant work experience: validations in an FDA regulated environment, writing protocols, performing & writing reports.
  • Experience in GMP/GDP environment highly desirable.
  • Advanced computer skills, including Microsoft Office Suite applications.
  • Strong communication and interpersonal skills.
  • Ability to effectively communicate technical information verbally and in writing to peers and senior management.
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