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Team Lead, Post Market Quality Engineering Specialist

2 months ago

Bloomington Indiana, United States Cook Group Full time

Job Summary:

The Post Market Quality Engineering Team Lead and Quality Assurance Manager at Cook Group is responsible for the effectiveness and efficiency of a quality engineering team and their ability to complete their projects/tasks.

This position teaches and mentors team members about processes/systems in addition to Cook Group policy, culture, and history. This position also communicates with other departments to identify and troubleshoot potential job-related issues.

Key Responsibilities:

  • Provide technical and non-technical direction for executing complaint investigations, post-market product surveillance, and supporting field actions as necessary.
  • Monitor and support investigations and give input on team resources.
  • Assign, adjust, and monitor work to meet deadlines.
  • Provide direct and frequent positive and constructive feedback on performance and areas for improvement to team members through informal and formal means.
  • Review and, where appropriate, approve team member documentation, specifically Quality Engineering Risk Analyses, Health Risk Assessments, and other risk documentation.
  • Able to work in collaborative and independent work situations and environments with minimal supervision.
  • Provide feedback to management on areas for improvement and training from a systems and personnel standpoint.
  • Conduct complaint investigations as needed per ISO standards.

Requirements:

  • Masters degree in Engineering, Science, or Medical discipline or MBA with 5 years relevant experience; or BS degree in same with 3 years relevant experience.
  • A minimum of 2 years Cook Group experience preferred.
  • Proficiency in statistical, quality, and continuous improvement methods.
  • Knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971).
  • A history of high performance demonstrating proficiency in several of the above-listed job functions/duties. Dependent upon demonstrated proficiency, significantly skilled individuals lacking in the minimum length of experience or education listed above may be considered for this position.

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.
  • Proper attire/clothing and personal protective equipment/clothing as required within Controlled Production Areas.