What are the responsibilities and job description for the Manufacturing Specialist position at RevereIT LLC?
Job Title : Validation Engineer
Location : Rochester, NY
Job Type : 12-Month Contract
Job Description :
We are seeking a skilled Validation Engineer with a strong background in Oracle, SQL, and software quality assurance for a medical device company. The ideal candidate will have extensive experience in validation and verification , including test script generation and software validation processes to ensure compliance with industry standards.
Key Responsibilities :
- Develop, execute, and maintain validation and verification test scripts for software and systems.
- Ensure compliance with FDA, ISO 13485, and other medical device regulations .
- Validate software and systems using Oracle and SQL databases .
- Collaborate with cross-functional teams, including Quality Assurance, Regulatory, and Development teams.
- Generate documentation and reports for validation activities, including protocols, test cases, and validation summaries.
- Conduct risk assessments and analyze system performance.
- Identify, document, and resolve validation-related issues in compliance with industry standards.
- Support audits and regulatory inspections by providing validation documentation and evidence .
Required Qualifications :
Preferred Qualifications :
