Team Lead, Post Market Quality Engineering

The Post Market Quality Engineering Team Lead at Cook Incorporated 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 policy, culture, and history.  This position also communicates with other departments to identify and troubleshoot potential job related issues.

• 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

• Masters degree in Engineering, Science, or Medical discipline or MBA with 5 years relevant experience; or BS degree in same with 3 years relevant exp.
• A minimum of 2 years Cook 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

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