| Hiring for a Validation Engineer for Warsaw, IN at Warsaw, New York, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2795034&uid=a87ac971ed12469f83655a0a98272048 From: Arjun, noviainfotech [email protected] Reply to: [email protected] Hi, Rate: $65 Validation Engineer Location: Warsaw, IN Duration: 12 months Openings: 3 positions Position: Process Validation Engineer (Medical Devices) Key Responsibilities Develop & Execute Validation Strategies: Create and implement process validation plans, protocols (IQ, OQ, PQ), and risk assessments for medical devices and equipment. Ensure Regulatory Compliance: Maintain adherence to FDA (21 CFR 820), ISO 13485, and other relevant regulations; participate in audits and stay updated on compliance requirements. Analyze Data & Reporting: Compile and analyze validation data, prepare comprehensive reports, and identify trends for continuous process improvement. Cross-Functional Collaboration: Partner with Manufacturing, QA, and Engineering teams to implement cleaning strategies, resolve issues, and provide technical support. Continuous Improvement: Lead initiatives for change control, troubleshooting, documentation, and training. Documentation & Technical Support: Create and maintain controlled documents including prints, procedures, BOMs, and routers. Process & Equipment Support: Support applications such as machining, forging, casting, finishing, molding, heat treating, bonding, and cleaning. Conduct feasibility studies to estimate product cost, equipment capacity, and capability requirements. Establish and improve process methods to meet performance and quality standards. Project Execution: Develop and manage project plans, schedules, and communication with cross-departmental teams. Equipment Qualification: Execute equipment qualification and process validation projects. Required Experience & Skills Strong background in process validation within the medical device or regulated industry. Hands-on experience with IQ, OQ, PQ protocols. In-depth knowledge of FDA (21 CFR 820), ISO 13485, and regulatory compliance. Proficiency in data analysis, technical reporting, and process troubleshooting. Excellent communication (written & verbal) and cross-functional collaboration skills. Keywords: quality analyst Hiring for a Validation Engineer for Warsaw, IN [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=2795034&uid=a87ac971ed12469f83655a0a98272048 |
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| 04:27 AM 26-Sep-25 |