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Senior Technical Quality Assurance Lead

1 month 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. This role will be responsible for leading and influencing discussions within the team and with other functional personnel to progress projects and tasks.

Key Responsibilities

  • Manage multiple project timelines, resources, and responsibilities to achieve team, departmental, and company goals.
  • Identify and escalate problems/obstacles to appropriate management levels and implement possible solutions.
  • Provide guidance and assistance to engineers and other technical employees/co-ops/interns/contractors.
  • Lead long-term planning efforts to improve monitoring, metrics, and analytical models to support QS and product continual improvement.

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.

Preferred Qualifications

  • 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.

Working Conditions

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.