Job Description
**Job Title : Software Design Quality Lead**
Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.
But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.
The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.
**In this role, you have the opportunity to**
Ensure every Innovation & Design software release is **safe, compliant, and audit-ready** by embedding **ISO/IEC medical software quality and regulatory-grade rigor** into a high-velocity delivery engine (200+ releases/year).
**You are responsible for**
+ **Important responsibility #1** : Lead the day-to-day execution of a Bangalore-based team of Quality Engineers (planning, prioritization, coaching, performance, hiring support), ensuring predictable delivery across a high-release cadence.
+ **Important responsibility #2** : Own the **software quality strategy** for medical software—driving compliance to relevant **ISO/IEC standards and QMS requirements** (e.g., ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, IEC 82304-1, and related procedures).
+ **Important responsibility #3** : Establish and enforce **release readiness criteria** (risk-based test coverage, traceability, defect thresholds, verification evidence, and documentation completeness) to enable frequent, confident releases.
+ **Important responsibility #4** : Build and continuously improve a **scalable verification approach** (risk-based testing, automated regression, CI/CD quality gates, test environment strategy, and test data management) to sustain 200+ releases/year without compromising compliance.
+ **Important responsibility #5** : Ensure **end-to-end traceability and evidence** across requirements → risks → design → verification (including review records, test protocols/results, defect management, and DHF/technical file contributions where applicable).
+ **Important responsibility #6:** Partner with Regulatory, Systems, Security, and Product to support **audits/inspections** , manage **CAPA** , deviations/nonconformances, and drive root-cause corrective actions through to closure.
+ **Important responsibility #7** : Define and track **quality KPIs** (escape rate, automation coverage, cycle time, defect trends, flaky tests, audit findings) and drive continuous improvement initiatives across the SDLC.
**You are a part of**
You will be part of the **Innovation & Design** organization, operating at the intersection of Engineering, Product, and Regulatory/Quality to ensure rapid innovation is delivered with medical-grade assurance.
The team culture emphasizes **ownership, transparency, continuous improvement, and strong collaboration** , with a focus on building sustainable processes and automation that scale with frequent releases.
**To succeed in this role, you should have the following skills and experience**
+ Important criteria #1 Master’s degree in **Computer Science, Software Engineering, Electronics, Biomedical Engineering** , or a related field.
+ Important criteria #2 Demonstrated experience leading QA for **medical device software / SaMD** in a regulated environment with working knowledge of **ISO/IEC medical software standards and QMS practices** (e.g., ISO 13485, ISO 14971, IEC 62304/82304; audit readiness and design control evidence).
+ Important criteria #3 Strong hands-on capability in **test strategy + execution at scale** , including **risk-based testing** , **test automation** , **CI/CD quality gates** , requirements/defect traceability, and common tooling (e.g., ALM tools, Git-based workflows, CI systems, test automation frameworks).
+ Important criteria #4 Proven people leadership with the ability to **prioritize under pressure, influence cross-functionally, communicate clearly with stakeholders, mentor engineers, and drive continuous improvement** while maintaining compliance discipline.
+ Important criteria #5 Relevant certifications such as **American Society of Quality- Certified Software Quality Engineer(CSQE), Certified Quality Auditor(CQA)** , or formal training in **ISO 13485 / ISO 14971 / IEC 62304** , plus experience with **software cybersecurity** expectations for medical devices and secure SDLC practices.
**How we work at Philips**
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
Our hybrid working model is defined in 3 ways:
_We believe in the importance of impactful collaboration:_ There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
_We embrace flexibility:_ Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
_We want to be at our best:_ The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.
**Why should you join Philips?**
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.
Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.
But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.
The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.
**In this role, you have the opportunity to**
Ensure every Innovation & Design software release is **safe, compliant, and audit-ready** by embedding **ISO/IEC medical software quality and regulatory-grade rigor** into a high-velocity delivery engine (200+ releases/year).
**You are responsible for**
+ **Important responsibility #1** : Lead the day-to-day execution of a Bangalore-based team of Quality Engineers (planning, prioritization, coaching, performance, hiring support), ensuring predictable delivery across a high-release cadence.
+ **Important responsibility #2** : Own the **software quality strategy** for medical software—driving compliance to relevant **ISO/IEC standards and QMS requirements** (e.g., ISO 13485, ISO 14971, IEC 62304, IEC 62366-1, IEC 82304-1, and related procedures).
+ **Important responsibility #3** : Establish and enforce **release readiness criteria** (risk-based test coverage, traceability, defect thresholds, verification evidence, and documentation completeness) to enable frequent, confident releases.
+ **Important responsibility #4** : Build and continuously improve a **scalable verification approach** (risk-based testing, automated regression, CI/CD quality gates, test environment strategy, and test data management) to sustain 200+ releases/year without compromising compliance.
+ **Important responsibility #5** : Ensure **end-to-end traceability and evidence** across requirements → risks → design → verification (including review records, test protocols/results, defect management, and DHF/technical file contributions where applicable).
+ **Important responsibility #6:** Partner with Regulatory, Systems, Security, and Product to support **audits/inspections** , manage **CAPA** , deviations/nonconformances, and drive root-cause corrective actions through to closure.
+ **Important responsibility #7** : Define and track **quality KPIs** (escape rate, automation coverage, cycle time, defect trends, flaky tests, audit findings) and drive continuous improvement initiatives across the SDLC.
**You are a part of**
You will be part of the **Innovation & Design** organization, operating at the intersection of Engineering, Product, and Regulatory/Quality to ensure rapid innovation is delivered with medical-grade assurance.
The team culture emphasizes **ownership, transparency, continuous improvement, and strong collaboration** , with a focus on building sustainable processes and automation that scale with frequent releases.
**To succeed in this role, you should have the following skills and experience**
+ Important criteria #1 Master’s degree in **Computer Science, Software Engineering, Electronics, Biomedical Engineering** , or a related field.
+ Important criteria #2 Demonstrated experience leading QA for **medical device software / SaMD** in a regulated environment with working knowledge of **ISO/IEC medical software standards and QMS practices** (e.g., ISO 13485, ISO 14971, IEC 62304/82304; audit readiness and design control evidence).
+ Important criteria #3 Strong hands-on capability in **test strategy + execution at scale** , including **risk-based testing** , **test automation** , **CI/CD quality gates** , requirements/defect traceability, and common tooling (e.g., ALM tools, Git-based workflows, CI systems, test automation frameworks).
+ Important criteria #4 Proven people leadership with the ability to **prioritize under pressure, influence cross-functionally, communicate clearly with stakeholders, mentor engineers, and drive continuous improvement** while maintaining compliance discipline.
+ Important criteria #5 Relevant certifications such as **American Society of Quality- Certified Software Quality Engineer(CSQE), Certified Quality Auditor(CQA)** , or formal training in **ISO 13485 / ISO 14971 / IEC 62304** , plus experience with **software cybersecurity** expectations for medical devices and secure SDLC practices.
**How we work at Philips**
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
Our hybrid working model is defined in 3 ways:
_We believe in the importance of impactful collaboration:_ There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
_We embrace flexibility:_ Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
_We want to be at our best:_ The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.
**Why should you join Philips?**
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.
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