02 Oct
|
Philips
|
Bengaluru
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 prospect
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 quality, data integrity, regulatory, and business risk.
- Author, review, and approve validation and assurance deliverables, including validation plans, requirements and specifications, risk assessments, protocols or test evidence, traceability documentation, deviations, reports, and validation summaries.
- Ensure electronic r
📌 NPSS Quality Assurance Manager (Bengaluru)
🏢 Philips
📍 Bengaluru