General Manager - Ellettsville

Posting Date 2 weeks ago(6/2/2021 8:54 AM)
Requisition ID
Job Location(s)
Ellettsville IN United States
Position Type
Full Time
Cook Inc.


The General Manager at Cook Incorporated manages day to day operations and provides leadership and direction to the functional team(s), ensures consistently high standards of quality, reproducibility and delivery are maintained in the development and continuous manufacturing of medical devices. Monitors competencies for continual improvement to meet Cook quality and business objectives.


• Ensure operational compliance with all applicable regulatory requirements including, QSP, SOP, Quality Policy, ISO13485, GMP and company policy manual
• Ensure product delivery standards are met
• Ensure that adequate resources are available for all operational activities
• Identify, analyze and make recommendations regarding personnel, equipment, space and processes.
• Ensure that training, support, direction and guidance are provided to all personnel
• Oversee enforcement of manufacturing procedures related to CMA, safety, tooling and equipment
• Maintain metrics for productivity and evaluations

• Ensure safety procedures are in place and adhered to by employees

• Meet or exceed all OSHA requirements
• Appraise personnel behaviors, productivity, quality, growth and ability to meet Cook objectives

• Continually improve all aspects of the facility with a focus on safety, quality, delivery and cost.
• Implement policies, programs and directives of global functions/management
• Foster and maintain a workplace culture respectful and supportive of individual differences

• Represent Cook at community functions and support the community in line with Cook's goals and objectives (ie Community Board member)

• Serve as Corporate Social Responsibility representative for the site
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth
• Adhere to the Quality Management System to ensure meeting FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements, driving quality throughout the organization


• Bachelors degree in Engineering, Business Management or a related field; or experience of such kind and amount as to provide a comparable background required
• 10 years of related industry experience
• 5 years in a leadership role
• Computer proficiency, experience with Microsoft products (Word, Outlook, Excel)
• Sound administrative skills and well developed management skills


Physical Requirements:

• General office setting
• Exposure to moderate noise and light levels within manufacturing facility
• Requires close visual acuity when working with computers, etc.
• Maintain a physical presence throughout the facility/facilities


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