Principal Quality Engineer

3 days ago

Bloomington, Indiana, United States Cook Medical Full time
Job Summary

We are seeking a highly skilled and experienced Principal Quality Engineer to join our team at Cook Medical. As a key member of our Quality Assurance team, you will be responsible for ensuring the quality of our medical devices and systems, and for providing strategic guidance on quality system statistics, data analytics, and risk management.

Key Responsibilities
  • Lead and influence discussions within the team and with other functional personnel to progress projects and tasks.
  • Manage multiple project timelines, resources, and responsibilities to achieve team, departmental, and company goals.
  • Identify and escalate problems and obstacles to appropriate management levels and implement possible solutions.
  • Present project status updates to team members and global functional leaders/executives as necessary.
  • Provide guidance and assistance to engineers and other technical employees, and review and approve outputs as necessary.
  • Lead long-term planning efforts to improve monitoring, metrics, and analytical models to support QS and product continual improvement.
  • Provide strategic guidance for corporate and global quality system statistics, data analytics, and risk management.
  • Demonstrate deep quality system, data, and risk knowledge, including process and regulatory details.
Requirements
  • Bachelor's degree in Engineering, Life Science, or similar field; Master's or PhD preferred.
  • Minimum 10 years experience working with quality management systems, engineering principles, and statistics.
  • Minimum 10 years experience in a regulated industry, preferably in a medical manufacturing environment.
  • Expertise with statistical practices, including sample sizes, confidence intervals, capability, assessing risk, and problem-solving experience.
  • Experience in communication and working with a wide variety of associates.
  • Experience working independently and directing others toward a common goal.
  • Proficiency in Microsoft Office suite of products, JBase, Engineering Server, Business Objects, and statistical software.
  • Strong organizational skills, critical thinking, and attention to detail required.
Physical Requirements
  • Works under general office environmental conditions, including time in manufacturing environment and biohazard lab.
  • Sitting for extended periods, utilizing close visual acuity for working with computers, equipment, etc.
  • Occasional travel may be required.

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