Quality Systems Engineer
Job Summary
Supporting the digital transformation and continuous improvement of Quality Management System technologies, the remote Quality Systems Engineer will manage Computer System Validation activities, digital workflows, and Quality data analytics for a global medical device organization.
Key responsibilities
- Own CSV/Computer Software Assurance activities for eQMS platforms and other computerized applications supporting Quality processes
- Serve as a Quality functional SME for eQMS and ERP Quality modules, translating business requirements into effective digital workflows
- Develop and maintain Quality metrics, dashboards, and reporting tools to analyze data and identify improvement opportunities
Required qualifications
- Bachelor's degree in Engineering, Computer Science, Information Systems, Quality, Life Sciences, or a related technical discipline
- 3+ years of experience in Quality Systems, Quality Engineering, or computerized system validation within a regulated industry
- Working knowledge of 21 CFR Part 11, FDA QMSR, and ISO 13485
- Familiarity with Computer Software Assurance, CSV, GAMP 5, and risk-based validation principles
- Strong analytical skills with experience in analyzing and presenting Quality or operational data
Complete Job Description
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