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Quality Engineer - Medical Devices - North PR region

Company

Integrated Services For Productivity & Validation, Inc

Location

Dorado, PR

Posted

June 26, 2026

Position Overview

Support multiple new line development projects by executing Tool Qualifications (TQFs), Operational Qualification (OQ), Performance Qualification (PQ), Test Method Validation (TMV), and In-Process Monitoring (IPM) by leveraging automated tools and site-level expertise. Scope of Work Execute and/or approve: OQ (Operational Qualification) PQ (Performance Qualification) TMV (Test Method Validation) IPM (In-Process Monitoring) Apply technical judgment to: Confirm applicability of validation documentation and risk documentation Identify discrepancies such as missing, conflicting, or outdated records Ensure alignment with: Current procedures Global validation standards Remediation expectations and timelines Key Responsibilities 1. Validation Engineer Validate multiple processes as needed/applicable following site practices and documentation Cross-check validation records against: MVPs (Master Validation Plans) PRAs (Product Risk Assessments) Supporting validation documentation Identify and q...

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