Principal Quality Assurance Engineer
Core
Lead technical expert for quality activities in the development and support of new and current medical devices, ensuring regulatory compliance and process improvement.
Role type
Principal Quality Assurance Engineer (Medical Devices)
Builds
Medical device products and manufacturing processes
Domain
Medical Devices / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, Failure investigation, Statistical analysis, Design of Experiments (DOE), Risk assessment and mitigation, Data interpretation, IQ/OQ/PQ development and execution, Process validation, Equipment qualification, Test method validation, Design controls, Verification and validation planning, CAPA management, Internal auditing, Regulatory compliance assessments, Quality metrics analysis, Project leadership, Facilitation skills, Conflict resolution, Stakeholder management, Supplier collaboration, Mentoring and coaching, Technical training, Knowledge transfer, Performance guidance, Continuous improvement methodologies, Subject matter expertise
Preferred skills
Lean-Six-Sigma experience
Technologies
FDA QSR/21 CFR 820, ISO 13485, ISO 14971
Responsibilities
Support New Product Development/Design Control by performing quality engineering activities such as design inputs, outputs, verification, validation, transfer, and risk analysis. Generate qualification verification, and/or validation plans, protocols, and reports for new or updated manufacturing processes and equipment (IQ/OQ/PQ). Review product and process changes and assess impact on product reliability and qualification/validation status. Lead and participate in quality metrics reviews, identifying weaknesses and risks associated with products and tracking mitigation. Facilitate cross-functional teams in performing complaint investigations and CAPA activities. Disposition materials/components rejected for non-conformance with effective corrective actions. Coordinate with suppliers and supply chain to improve quality, cost, and delivery. Provide support for sales force and customers to resolve product technical questions and instrument performance concerns.
Seniority
Principal, technical leadership & mentorship
