Team Lead, Post Market Quality Engineering - ref. u94600423
Bloomington
Overview:
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.
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
Qualifications:
- 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
Spencer (IN), 15 mi from Bloomington (IN)
Overview:
The Post Market Sustaining Engineering Team Lead at Cook Incorporated is responsible for the effectiveness and efficiency of a sustaining engineering team and their ability to complete their projects/tasks. This position teaches...
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Position Description:
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