Quality Engineer 2- Risk Management

Posting Date 4 weeks ago(8/30/2022 11:39 AM)
Requisition ID
Job Location(s)
Bloomington IN United States
Position Type
Full Time
Cook Inc - Bloomington


The Risk Management Quality Engineer at Cook Inc. supports functional areas on proper implementation and execution of risk management activities used throughout the lifecycle of a medical device. The Quality Engineer, Risk Management is responsible for revisions of risk management policies and procedures, and  ensures procedures, processes, and files are sustainable and in compliance with applicable standards and regulations.


• Drive continuous improvement efforts related to risk management throughout the organization
• Develop required training and participate in execution of training
• Lead or assist in completion of risk documents (e.g. FMEA, Benefit/Risk Analysis, Hazard Analysis) as required
• Work with other functional areas to ensure the proper application, use, and updates of risk management files
• Support various production, engineering, quality, clinical, and technical teams in the evaluation of data as it relates to risk assessment
• Assist with EU MDR technical file submissions and responses.

• May interface with internal, 3rd party audits e.g. FDA, Notified Body, etc.

• Manage conflict resolution as it relates to technical situations


• Bachelors of Science in Engineering or related technical field
• In-depth knowledge of risk management per ISO 14971 applied to medical devices
• Work experience within the medical device industry and trained to quality system regulations (21CFR820, ISO 13485)

• Demonstrated application of risk management throughout entire product lifecycle (Design, Supplier Controls, Manufacturing, Post-Market, CAPA)

• Experience in defending on-site internal and external audits and communicating with notified bodies to resolve non-conformances/queries is preferred.
• Strong statistical analysis skills preferred
• Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) preferred


Physical Requirements:

• Limited travel required

• This is a remote position and can be based anywhere within the US. A virtual employee may be required to make periodic visits to a Cook Facility based on manager and leadership discretion. 

• Frequently required to stand, walk, use hands to grasp, carry, feel or touch; reach with hands and arms; stoop, kneel, crouch; talk and hear
• Proper attire/clothing and personal protective equipment/clothing, as required, within Controlled Production Areas


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