Senior Software Validation and Quality Engineer
Technology
Job Description
Software Validation and Quality Engineer
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6-month Contract
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Hybrid in Weston, FL
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Must be able to work on a W2
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We are seeking an experienced Software Validation / Quality Engineer to support internally developed software used in the design of patient-matched orthopedic implants.
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This individual will lead software validation activities, establish a scalable validation approach, and partner closely with Software Engineering, Quality, and Regulatory teams.
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Key Responsibilities:
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- 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
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Ideal Background:
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- 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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