Senior Software Validation and Quality Engineer

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gforce life sciencesWeston (FL)

Validation Engineers Surgical Appliance and Supplies Manufacturing

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About the role

Software Validation and Quality Engineer 6-month Contract Hybrid in Weston, FLMust 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: Develop and execute software validation strategies, protocols, test plans, and documentation Define validation requirements based on intended use, functionality, and risk Support validation of internally developed software used in medical device design Ensure compliance with applicable medical device quality and regulatory requirements Develop/improve SOPs and validation processes for future software releases Work independently and cross-functionally to drive validation activities through completion Ideal Background:5+ years of software validation, software quality, or CSV experience; 8+ years preferred Medical device or other highly regulated industry experience Experience validating internally developed/custom software Strong knowledge of software validation documentation, risk-based validation, and quality systems Experience with medical device regulations and standards strongly preferred

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