Quality Engineer - Medical Devices - North PR region

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of validation documentation and risk documentation Identify discrepancies such as missing, conflicting, or outdated records Ensure alignment with: Current procedures Global validation standards Remediation expectations and timelines Key Responsibilities 1.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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