Principal Engineer Quality
Core
Act as site Subject Matter Expert (SME) for validation of equipment, sterile packaging, mixing, water systems, filling systems, cleaning processes, and injection molding processes in medical device manufacturing.
Role type
Principal Engineer Quality (Validation)
Builds
Validated medical device production equipment, testing equipment, and facility utilities
Domain
Medical Device Manufacturing / Quality Assurance
Required skills
Risk-based approach (CPPs/CQAs), IQ/OQ/PQ protocol design and execution, Validation Master Plan development, Deviation and change control management, Regulatory compliance (ISO 13485, FDA 21 CFR 820, EU MDR), Statistical sampling methods, Technical writing (English)
Preferred skills
Cleanroom and utility system qualification, Cross-functional coordination, Audit support
Technologies
CIP/COP, Aseptic filling, Injection molding, Water systems (PW/WFI), Testing equipment
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/external audits, Ensure compliance with medical device GMP requirements
Seniority
Principal, hands-on IC