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.

CSV / CSA and Quality Assurance

Experience

Office-based

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.

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 records, electronic signatures, audit trails, access controls, data migration, interfaces, backup and restore, and data integrity controls are appropriately assessed and verified where applicable.

Advise projects using Agile, DevOps, cloud, SaaS, configurable platforms, ERP, QMS, manufacturing, analytics, and other enterprise applications on compliant lifecycle controls and objective evidence.

Assess and leverage supplier documentation and automated testing evidence where justified through documented risk and quality decisions.





Ensure validated systems remain in a controlled state through change impact assessments, periodic reviews, issue and CAPA management, and lifecycle monitoring.

Prepare for and support internal audits, external audits, and regulatory inspections. Lead cross-functional resolution of complex quality and compliance issues, facilitate risk-based decisions, and escalate significant compliance risks when needed.

Drive measurable improvements in validation efficiency, right-first-time quality, standardization, automation, and inspection readiness without weakening compliance controls.

Coach and mentor validation engineers, validation leads,u00A0 system owners, testers, and project team members, and develop or deliver role-based training on lifecycle and assurance requirements.

Bacheloru2019s or masteru2019s degree in engineering, computer science, information systems, life sciences, quality, or a related technical field, or equivalent relevant experience.

Minimum 8-12 years of relevant experience in computerized systems, software quality, validation, quality assurance, or quality systems within medical devices, pharmaceutical, biotechnology, diagnostics, or another highly regulated life sciences industry.

Demonstrable hands-on experience planning, authoring, executing, reviewing, and approving CSV or CSA deliverables for complex computerized systems.

Robust working knowledge of risk-based validation, data integrity, electronic records and signatures, configuration and change control, supplier assurance, and maintaining systems in a validated state.

Experience supporting audits or inspections and explaining and defending validation strategies, risk decisions, and objective evidence to auditors or regulators.

Ability to translate regulatory and quality requirements into practical controls for business, IT, and project teams.

Excellent technical writing, facilitation, stakeholder management, and verbal communication skills in English.





Ability to influence without direct authority, manage competing priorities, and make well-reasoned quality decisions in a matrix organization.

Regulatory and industry knowledge

FDA Quality System Regulation / Quality Management System Regulation, including controls applicable to production and quality system software

- ISO 13485 quality management system requirements and data integrity expectations
- FDA Computer Software Assurance guidance and risk-based assurance concepts
- ISPE GAMP 5 (A Risk-Based Approach to Compliant GxP Computerized Systems) principles and recognized good practices for computerized system lifecycle management
- Agile and DevOps delivery models, cloud and SaaS platforms, automated testing, and supplier-managed services.
- Hands-on experience validating enterprise platforms such as ERP, eQMS, PLM, MES, LIMS, CRM, data and analytics platforms, or regulated workflow applications.
- Experience working with validation workstreams, governance forums, remediation programs, or global process improvement initiatives.
- Professional certification or formal training in quality, auditing, software quality, validation, risk management, or project management.
- Experience with requirements, test management, electronic validation lifecycle management, or automated testing tools.

Validation strategies and deliverables are proportionate to risk, complete, traceable, and accepted right first time.

Projects receive early, practical quality guidance and avoid late compliance rework.

Systems remain inspection-ready and in a validated state throughout their operational life.

Audit and inspection questions are answered clearly with readily available, defensible evidence.

Project teams adopt consistent, efficient assurance practices and demonstrate increased capability.

For our office-based teams, this means working in-person at least 3 days per week.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

If youu2019re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply.

📌 Quality Assurance Manager - Full Time (Bengaluru)
🏢 Philips
📍 Bengaluru