Principal Engineer Quality
Core
Act as a Subject Matter Expert for validating medical device manufacturing equipment, sterile packaging, water systems, and cleaning processes to ensure compliance with regulatory standards.
Role type
Principal Engineer Quality (Validation)
Builds
Validated medical device production equipment, utilities, and processes
Domain
Medical Device Manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
IQ/OQ/PQ validation, risk-based approach (CPP/CQA), deviation management, change control, audit support, regulatory compliance (ISO 13485, FDA 21 CFR 820, EU MDR), statistical sampling methods
Preferred skills
Cleanroom operations, utility system qualification, cross-functional coordination
Technologies
Validation databases, statistical software
Responsibilities
Define critical process parameters and quality attributes, draft and approve validation protocols and reports, lead on-site validation execution, manage deviations and change controls, support internal and external audits
Seniority
Principal, hands-on IC with strategic oversight
