Senior Software Validation and Quality Engineer

Job Description

Software Validation and Quality Engineer

6-month Contract

Hybrid in Weston, FL

Must be able to work on a W2

We are seeking an experienced Software Validation / Quality Engineer to support internally developed software used in the design of patient-matched orthopedic implants.

This individual will lead software validation activities, establish a scalable validation approach, and partner closely with Software Engineering, Quality, and Regulatory teams.

Key Responsibilities:

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• Develop and execute software validation strategies, protocols, test plans, and documentation
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• Define validation requirements based on intended use, functionality, and risk
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• Support validation of internally developed software used in medical device design
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• Ensure compliance with applicable medical device quality and regulatory requirements
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• Develop/improve SOPs and validation processes for future software releases
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• Work independently and cross-functionally to drive validation activities through completion
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Ideal Background:

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• 5+ years of software validation, software quality, or CSV experience; 8+ years preferred
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• Medical device or other highly regulated industry experience
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• Experience validating internally developed/custom software
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• Strong knowledge of software validation documentation, risk-based validation, and quality systems
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• Experience with medical device regulations and standards strongly preferred
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