Cook Medical Quality Control Manager in Bloomington, Indiana
The Quality Control Manager establishes directions and goals within one or more quality control departments and ensures conformance/compliance to internal procedures and external standards; and ensures adequate resources are available to meet delivery standards for internal and external products. This position interacts regularly with Operations Management to support global business direction & identify areas in need of improvement.
- Maintain first-hand understanding of the state of the department(s) by spending an effective amount of time in the department(s).- Ensure work order status is updated in a timely manner.- Maintain and evaluate KPI’s for productivity and evaluations.- Recognize, develop and utilize natural leaders.- Must be heavily involved with all personnel matters including employee performance issues, corrective action processes, and employeedevelopment plans and actions.- Drive quality and efficiency improvements.- Provide direction/guidance to ensure that expectations and goals are clear and understood.- Ensure work is being completed in a safe, sanitary and orderly environment.- Ensure area functions effectively independent of leadership oversight.- Support audits, investigations and tours within the department.- Ensure compliance of, and adherence to, internal procedures and processes.- Initiate actions to improve quality and efficiency.- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
- High School Diploma or GED required.- Bachelors degree in Engineering, Management or a related field; or experience of such kind and amount as to provide a comparable background preferred.- Minimum 2 years experience in manufacturing management preferred.- Knowledge of/or training in ISO, GMP and CFR standards.- Computer proficiency, experience with Microsoft products (Word and Excel).
• Must be able to sit at desk, in meetings and/or work on a computer• Physically capable of standing, stooping, kneeling, climbing, reaching, twisting and bending with or without reasonable accommodation• Climbing a mobile ladder and/or other types of ladders on occasion with or without reasonable accommodation• Must perform PPE gowning procedures to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required on occasion
• Potential limited exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required• Ability to work under specific time constraints• Laboratory, warehouse and office setting
Posting Date2 weeks ago(6/3/2021 3:22 PM)
Requisition ID 2021-9048
Job Location(s) Bloomington IN United States
Position Type Full Time
Company Cook Inc.