Quality Assurance Manager

Posting Date 1 month ago(4/29/2022 3:08 PM)
Requisition ID
2022-10707
Job Location(s)
Bloomington IN United States
Travel
10-20%
Shift Type
First
Position Type
Full Time
Company
Cook Medical Inc.
Category
Quality

Overview

The Quality Assurance Manager at Cook Medical is responsible for working with process owners, subsystem leaders and other functions in helping to maintain a compliant, effective and efficient quality system for the AMER Support Center and AMER Distriburtion Center.

Responsibilities

• Serve as site Management Representative - host audits, identify appropriate quality data, provide independent review of quality system performance at all levels and reporting any issues
• Facilitate third party audits and inspections; coordinate responses to the audits/inspections and ensure that findings are addressed appropriately
• Ensure that the Quality Management System and the processes needed to ensure product quality are implemented, understood, and maintained
• Ensure that issues requiring improvement are identified and fed to CAPA appropriately
• Communicate directly with designee(s) at Cook manufacturing sites regarding changes made to the quality system affecting regulatory submissions
• Regularly monitor performance of the Quality Management System and communicate deficiencies to responsible personnel
• Communicate within the supply chain for matters relating to the quality system
• Maintain knowledge of federal, state, and local regulatory requirements applicable to work performed in the AMER Support Center and AMER Distribution Center 
• Refine and implement regulatory practices as needed to meet regulatory compliance
• Serve as process owner for Management Review
• 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

Qualifications

• Bachelor's degree Engineering or Life Science or experience of such kind and amount as to provide a comparable background

• Minimum 3 years experience in quality systems experience; management experience preferred
• Knowledge of quality tools and principles
• Knowledge of medical device regulations, pertinent standards and guidances
• Proven written and verbal communication and problem solving skills
• Basic knowledge of statistics
• Possess a working knowledge of ISO 13485 and other applicable standards

• Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

 

Physical Requirements:

• This position is a remote position, but may be required to make periodic visits to the facility, based on manager and leadership discretion
• Must reside within a 1-hour radius via car, of the Cook Medical LLC facility in Bloomington, Indiana

• Works under general office environment conditions

• Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
• Some travel may be involved

 

 

 

 

 

 

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