Post Market Quality Engineer

United States·Warsawmid

EngineeringQuality Engineer

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Quick Summary

Key Responsibilities

There are no supervisor responsibilities with this position.

Requirements Summary

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. (The requirements listed below are representative of the knowledge,

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EngineeringQuality Engineer

Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on advancing the field of pediatric orthopedics. As such it has developed the most comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 53 products that serve three of the largest categories within the pediatric orthopedic market. This product offering spans trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and over 70 countries outside the United States. For more information, please visit www.orthopediatrics.com.

Work within cross-functional internal and external teams to investigate device field complaints and provide solutions to resolve complaints in a timely manner.
Perform failure analysis of medical devices using various types of test equipment, fixtures, and software tools.
Utilize applicable quality tools (Root cause analyses) to ensure timely, accurate, and complete failure investigations of product complaints leading to the root cause and ensure that all activities are documented in the complaint management system.
Review internal and external documentation such as device history records, material certifications, inspection reports, and any additional supporting documentation for conformance for complaint investigations.
Comply with Quality Management’s guidance and instruction and provide complaint status updates.
Work with Product Line Engineers to complete post market risk assessments and drive periodic updates to risk management documentation and potentially other documents.
Develop, update, and maintain Job Aids and Work Instructions to facilitate and standardize investigation activities.
Ability to interface with external auditors.

Responsibilities

~1 min read

There are no supervisor responsibilities with this position.

Requirements

~1 min read

Work Environment: (The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

The noise level in the work environment is that found in a “normal office environment; noise levels during visits to other locations in the building may be moderate and occasionally loud. The employee will be required to travel 5% of the time.

The above statement reflects the general details necessary to describe the principle functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation.