Quality Validation Engineer - Equipment Validation
Core
Plan, coordinate, and manage equipment validation projects and supplier quality evaluations to ensure product development and production meet FDA, ISO, and customer quality deliverables.
Role type
Quality Validation Engineer (Equipment & Supplier)
Builds
Validated equipment and compliant drug delivery devices
Domain
Medical Device / Pharmaceutical Manufacturing
Required skills
Equipment validation (IQ/OQ/PQ), Supplier quality auditing, CAPA management, Statistical analysis (SPC, DOE), Technical writing, Regulatory compliance (FDA/ISO)
Preferred skills
Six Sigma certification, Medical device industry experience, SAP, Cleanroom manufacturing experience
Technologies
SAP, Microsoft Office
Responsibilities
Coordinate and manage execution of validations and creation of written protocols; Plan and audit supplier quality evaluations; Lead investigations regarding customer complaints and assess Corrective Actions; Develop and analyze statistical data to establish quality improvements; Assist in maintaining ISO and FDA QSR quality systems compliance; Interact with customers and suppliers to ensure mutual interpretation of requirements.
Seniority
Mid-level, hands-on IC