NPSS Quality Assurance Manager
Core
Lead and execute compliant, risk-based assurance for computerized systems supporting medical device quality and business processes.
Role type
Senior IC Quality Assurance Manager (CSV/CSA)
Builds
Validated computerized systems for medical devices and regulated life sciences
Domain
Medical devices / Regulated life sciences / Computer System Validation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer System Validation (CSV), Computer Software Assurance (CSA), risk-based validation, data integrity, electronic records and signatures, configuration and change control, supplier assurance, audit readiness, stakeholder leadership, technical writing
Preferred skills
Enterprise platform validation (ERP, eQMS, PLM, MES, LIMS, CRM), global process improvement, professional certification in quality/auditing/risk management, automated testing tools
Technologies
ERP, eQMS, PLM, MES, LIMS, CRM, data and analytics platforms, cloud, SaaS, Agile, DevOps
Responsibilities
Develop and maintain CSV/CSA deliverables and procedures, author validation plans and risk assessments, support internal/external audits and regulatory inspections, coach and mentor validation teams, drive improvements in validation efficiency and automation
Seniority
Senior, hands-on IC