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Sr. Development Quality Engineer

Atlanta, GA 30313

Posted: 06/01/2023 Employment Type: Contract Job Category: Engineering Job Number: 566631 Is job remote?: No Country: United States

Job Description

Target PR Range: 50-56/hr
*Depending on experience

The Sr. Development Quality Engineer will serve as a technical representative providing design quality expertise to a product development team.  Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient/user safety, customer satisfaction, and organizational success.  
 
Responsibilities:
•    Support the establishment of objective, measurable, and verifiable product requirements
•    Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities
•    Lead Risk Management activities from product concept through commercialization
•    Support test method development and lead test method validation activities
•    Support audits and quality system improvement activities
•    Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
•    Comply with U.S. FDA, EUMDR and other requirements, as applicable.   
•    Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.
 
Qualifications:
•    Bachelor’s degree in Engineering or Technical Field.  Electrical Engineering preferred
•    Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality
•    Experience in electro-mechanical medical devices and associated regulations/standards. 
•    Experience in electrical engineering and/or medical device electrical safety
•    Experience in preparing risk assessments, FMEA and other risk documents.
Preferred Qualifications:
•    Advanced Degree in Electrical Engineering or Biomedical Engineering with concentration in electrical systems
•    Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA). 
•    Working knowledge of statistics and its application to verification and validation
 

 
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