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

Requisition ID2024-15182

Posting Date2 weeks ago(9/4/2024 9:18 AM)

Job Location(s)Bloomington IN United States

Job LocationsUS-IN-Bloomington

TravelLess than 10%

Position TypeFull Time

CompanyCook Inc - Bloomington

CategoryQuality