Sr Principal Engineer (Quality)
Core
Sr Principal Engineer leading CAPA activities, quality metrics, regulatory compliance, and cross-functional issue resolution for medical devices and drugs.
Role type
Sr Principal Engineer (Quality)
Builds
Quality systems, corrective actions, and regulatory compliance for medical devices and pharmaceuticals.
Domain
Medical Devices / Pharmaceuticals / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
CAPA management, root cause analysis, regulatory compliance (21 CFR 820, 210/211), post-market surveillance, risk assessment, cross-functional leadership, data analysis, change control
Preferred skills
CQE certification, Six Sigma, lean manufacturing, EN ISO14971, cGMP, QSR, ISO13485, FDA Design Control
Technologies
Excel (PivotTables, trending, charting)
Responsibilities
Develop and monitor quality metrics; guide development of new methodologies and processes; analyze complaint data for root cause; coordinate cross-functional investigations; serve as primary contact for regulatory inquiries and customer complaints; support New Product Development quality requirements; mentor engineering teams; ensure compliance with regulatory requirements and support audits.
Seniority
Sr Principal, hands-on IC with leadership