Npss Quality Assurance Manager Jobs

Job Title NPSS Quality Assurance Manager Job Description Job Title: NPSS Quality Assurance Manager Lead and execute compliant, risk-based assurance for computerized systems that support medical device quality and business processes. This role combines hands-on Computer System Validation (CSV), quality oversight, stakeholder leadership, and audit readiness across the system lifecycle. Focus CSV / CSA and Quality Assurance Experience 8+ years in regulated environments Work Model Office-based / Hybrid designation to be confirmed The opportunity As an NPSS QA Manager, you will own and strengthen the validation and assurance framework for non-product software and computerized systems used in a regulated medical device environment. You will partner with process owners, IT, Quality, Regulatory, Cybersecurity, Privacy, suppliers, and project teams to ensure systems are fit for intended use, compliant, inspection-ready, and maintained in a validated state. Your role Provide quality oversight and consultancy across the full computerized system lifecycle, including intended use, classification, validation planning, requirements, risk assessment, supplier assessment, test strategy, traceability, release, change control, periodic review, incident and problem management, and retirement. Develop, implement, and maintain computerized system validation deliverables, procedures, and guidance for CSV and Computer Software Assurance (CSA). Collaborate effectively with project teams and the NPSS team, consistently applying current GxP standards. Apply a risk-based, critical-thinking approach that scales assurance activities to patient safety, product qual

Job Title NPSS Quality Assurance Manager Job Description Job Title: NPSS Quality Assurance Manager Lead and execute compliant, risk-based assurance for computerized systems that support medical device quality and business processes. This role combines hands-on Computer System Validation (CSV), quality oversight, stakeholder leadership, and audit readiness across the system lifecycle. Focus CSV / CSA and Quality Assurance Experience 8+ years in regulated environments Work Model Office-based / Hybrid designation to be confirmed The opportunity As an NPSS QA Manager, you will own and strengthen the validation and assurance framework for non-product software and computerized systems used in a regulated medical device environment. You will partner with process owners, IT, Quality, Regulatory, Cybersecurity, Privacy, suppliers, and project teams to ensure systems are fit for intended use, compliant, inspection-ready, and maintained in a validated state. Your role Provide quality oversight and consultancy across the full computerized system lifecycle, including intended use, classification, validation planning, requirements, risk assessment, supplier assessment, test strategy, traceability, release, change control, periodic review, incident and problem management, and retirement. Develop, implement, and maintain computerized system validation deliverables, procedures, and guidance for CSV and Computer Software Assurance (CSA). Collaborate effectively with project teams and the NPSS team, consistently applying current GxP standards. Apply a risk-based, critical-thinking approach that scales assurance activities to patient safety, product qual