Quality Engineer II (Validation)
Core
Support and maintain Quality Systems across Media manufacturing plants, focusing on validation writing, execution, and compliance to ensure product quality and regulatory adherence.
Role type
Quality Engineer II (Validation)
Builds
Validated processes, equipment qualifications, and compliant quality systems for medical device manufacturing
Domain
Medical device manufacturing / Life sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation writing, risk assessment, statistical analysis (SPC, Six Sigma), root cause analysis, CAPA management, FDA 21 CFR 820 knowledge, ISO 13485/14971 knowledge, SOP development, change control management
Preferred skills
Technical writing, process and test method validation, medical device or pharmaceutical manufacturing facility experience, automated filling and packaging systems knowledge
Technologies
Enterprise quality systems, statistical tools (Six Sigma, SPC), risk assessment tools
Responsibilities
Develop and maintain Quality System procedures and SOPs; Lead and execute validation activities including change validations and equipment qualifications; Monitor and analyze quality indicators for materials and products; Assess Critical to Quality (CTQ) parameters and perform risk assessments; Initiate and support Corrective and Preventive Actions (CAPAs); Partner with cross-functional teams to support product launches and process improvements; Ensure compliance with FDA regulations and ISO standards; Serve as subject matter expert during internal and external audits
Seniority
Mid-level, hands-on IC
