Software Design Quality Lead

Job Title

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 its not just what we do its who we are. We are 80000 wonderfully unique individuals with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers needs. Its 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. Thats 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 softwaredriving 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 Masters 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: Theres a certain energy when everyones 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 isnt 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. Its 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.