Be the key conjunction point between the technical and the compliance aspects of the software solution. Oversee quality and risk management throughout the software lifecycle and provide competent support to the architecture, development and operation teams in efficiently combining technical and compliance aspects to maximize quality. You independently audit the adequacy of design specifications, Verification and Validation (V&V) strategies, and promote continuous improvements. You also collect and analyze data from performance in the field, evaluate it against reliability specifications for software and provide independent advice to the top management. We are open for candidates with an engineering background in Software who are open to move to the Quality field.
You are responsible for
Participating in Design and Development activities as independent advisor for the team, to propose and champion quality oriented decisions so that quality is embedded at the core of the solution since the early stages.
Acting as bridge between regulatory and technical world, providing expert guidance on how to efficiently apply compliance requirements to innovative software development solutions.
Acting as bridge between regulatory and technical world, promoting the evolution of processes and way of working to align with continuously evolving technology
Maintaining a good understanding of all disciplines and tasks involved in the software lifecycle (including but not limited to D&D (Design and Development), Verification and Validation, DevOps/Operations, Post market surveillance, tooling, deployment processes, continuous integration/continuous deployment and on current and emerging industry practices.
Owning risk management file and independently report current or potential issues to top management
Independently assess quality of the solution and advice top management on needed actions
Promoting and contributing to continuous improvement activities, knowledge sharing and alignment with centers of excellence and other Philips businesses so that best practices are identified and shared.
Acting as stakeholder and subject matter expert for quality during Design Reviews, Milestones/gates, audits and key decision meetings.
Providing competent support to the team during tool selection and validation, definition of strategies for release, deployment, verification, automation and monitoring.
Ensuring appropriate measures are established so that residual quality issues are identified before the solution is released
You are a part of
The Strategy and Innovation Platforms QMS team plans, controls and manages relevant Quality activities for key strategic platforms within the Philips organization. These platforms are used to host and build medical and non-medical devices for a variety of uses. Key customers include Philips Connected Care and Precision Diagnostics organizations and even organizations external to Philips.
The Strategy and Innovation Platforms team consist of 10 Quality professionals mostly based in Bangalore, India and Eindhoven, the Netherlands. You will be reporting directly to the Q&R Head for Strategy and Innovation Platforms.
To succeed in this role, you should have the following skills and experience
Bachelor/Master’s in engineering degree with > 2 years of experience in regulated software industry
Expert knowledge and understanding and knowledge of principles, theories, and concepts relevant to Software Quality Engineering
Coming from a regulated industry (Automotive, Aerospace, Pharma, Biotech, Medical Device, high tech companies with strong regulations)
Strong team player, open minded, out of the box thinking
Excellent documentation and communication skills and interpersonal relationship skills including influencing and negotiating
Working knowledge of standards and regulations applicable to medical software development, including but not limited to IEC62304, ISO13485, FDA QSR, EU MD (preference)
Must understand systems architecture, software development and maintenance processes including configuration management and defect management. Must understand verification and validation processes, including early software defect detection and removal, inspection, and testing methods (e.g., types, levels, strategies, tools, and documentation). Must be able to analyze V&V strategies, and spot non-obvious issues in the technical documentation
In return, we offer you
We welcome you to a challenging, innovative environment with great opportunities for you to explore.
Our benefits are very competitive and designed around your preferences:
A market conform salary
25 Days of leave and the possibility to purchase up to 20 extra days off annually
A variable bonus based on both Philips results and personal performance
Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
Solid company pension scheme and attractive collective health insurance package
Opportunity to buy Philips shares and products with discount
Healthy work-life balance
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 improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.
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