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Validation Engineer

QRC Group, LLCCaguas, PR, pr

Hace 1 día

Tipo de contrato

Quick Apply

Descripción del trabajo

Job Description

Validation Engineers to support the internal development and validation of a multi-dose preservative-free (MDPF) nozzle subsystem and any other miscellaneous project related deliverables as they arise .

Location : SouthEast, United States (Travel Required)

Scope Includes :

Validation of new molding and assembly units
Qualification of ISO7 clean rooms
Integration of metrology instruments and handling systems
Execution of IQ / OQ / PQ protocols, FAT / SAT, and traceability documentation
Collaboration on a comprehensive Validation Master Plan

Location : SouthEast, United States (Travel Required)

Requirements

Bachelor’s in Engineering (Mechanical, Biomedical, Chemical, or Industrial)

Location : SouthEast, United States (Travel Required)

Technical Skills

IQ / OQ / PQ protocol development and execution

FAT / SAT testing and documentation

Validation Master Plan (VMP) creation

MES / SCADA system qualification

Injection molding and automated assembly validation

Metrology equipment calibration and Gage R&R

Traceability Matrix development

Experience with KNEAT software (highly desirable)

Regulatory Knowledge

FDA 21 CFR Part 820

EU MDR 2017 / 745

ISO 13485 & ISO 14971

GMP compliance

Certifications

ISO 13485 Quality Management

ISO 14971 Risk Management

GMP Training

Six Sigma (Green or Black Belt)

Soft Skills

Strong documentation and report writing

Cross-functional collaboration

Ability to train personnel

Analytical thinking and problem-solving

Location : SouthEast, United States (Travel Required)

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Validation Engineer • Caguas, PR, pr

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