Senior QA Engineer
Senior QA Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Role Senior QA Engineer
Experience : 10 years
Location Atlanta GA
Client : ONWARD USA
Visa : Any
Outcomes
The Senior QA Engineer spearheads engineering quality throughout every stage of product development. Engineering Quality encompasses the deployment and upkeep of the customers Quality Management System ensuring product adherence to rigorous validation verification and implementation standards while fostering a culture of perpetual improvement optimizing efficiency minimizing defects and elevating customer satisfaction.
Design Controls
The Senior Quality Engineer will establish and maintain design inputs conduct risk assessments perform design reviews and document traceability of all CUSTOMERS devices and software ensuring that it meets the necessary performance and safety requirements throughout the design and development lifecycle.
Outcome
Key Result
Support CUSTOMERS Design Control Management.
Support the design control process to ensure that CUSTOMERS devices and software meets or exceeds quality standards
leading to reliable and safe Xray products.
Design and enforce design control processes to demonstrate compliance with regulatory requirements set forth by the FDA ISO 13485 and IEC.
Generate meticulous documentation of design inputs design outputs verification and validation activities providing evidence to demonstrate regulatory and customer compliance.
Execute systematic identification assessment and mitigation of potential risks associated with product design reducing the chances of harm.
Establish a framework for traceability ensuring that design decisions changes and verification/validation activities are documented providing accountability and enabling effective postmarket surveillance maintenance and continuous improvement efforts.
Employment Type
Full Time
