Senior Technical Quality Leader

2 days ago


Bloomington, United States Cook Medical Full time
Job Summary

We are seeking a highly experienced and skilled Principal Quality Engineer to join our team at Cook Medical. As a senior technical member of the global Quality Assurance team, you will provide strategic guidance on quality system statistics and data analytics, and risk management.

The ideal candidate will have a strong background in quality management systems, engineering principles, and statistics, with a minimum of 10 years of experience in a regulated industry, preferably in a medical manufacturing environment.

You will be responsible for leading and influencing discussions within the team and with other functional personnel, managing multiple project timelines and resources, and identifying and escalating problems to appropriate management levels.

Additionally, you will provide guidance and assistance to engineers and other technical employees, and lead long-term planning efforts to improve monitoring, metrics, and analytical models to support QS and product continual improvement.

Key Responsibilities:

  • Lead and influence discussions within the team and with other functional personnel
  • Manage multiple project timelines and resources
  • Identify and escalate problems to appropriate management levels
  • Provide guidance and assistance to engineers and other technical employees
  • Lead long-term planning efforts to improve monitoring, metrics, and analytical models

Requirements:

  • Bachelor's degree in Engineering, Life Science, or similar field
  • Minimum 10 years of experience working with quality management systems, engineering principles, and statistics
  • Minimum 10 years of experience in a regulated industry, preferably in a medical manufacturing environment
  • Expertise with statistical practices as it relates to sample sizes, confidence intervals, capability, assessing risk, and demonstrated 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 the Microsoft Office suite of products, JBase, Engineering Server, Business Objects, and statistical software

Physical Requirements:

  • Works under general office environmental conditions, including time in manufacturing environment and biohazard lab
  • Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
  • Occasional travel may be required


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