Philips Senior Software Quality Engineer in Eindhoven, Netherlands
As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
Can you take a pro-active yet pragmatic and incremental approach to ensure compliance with Quality Systems and regulations that govern product development activities within the department?
Do you have a holistic quality assurance strategy that comprises different quality assurance techniques in order to increase and prove product quality during all stages of product development?
Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech – focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).
As Quality Engineer Software you:
Are responsible for leading SW quality engineering activities like: Designing SW Quality plans, overseeing the execution of SW Quality Plans, assessing complex software designs and reviewing test and other complex performance data, analyses market feedback, lead complex root cause analysis and complex SW Quality problem solving.
Support and facilitate the department in enabling and assuring that products are developed and produced in compliance with requirements from applicable standards (process focus)
Act as single point of contact within a project for compliance related questions
Give guidance and actively contributes to all aspects related to quality, applicable regulatory requirements and Philips HealthTech policies and procedures
Embed Quality & Regulatory requirements in the design and build processes
Monitor that the QMS procedures are followed, does everything needed to facilitate the team in following them
Support in applying requirements of applicable standards (ISO13485, IEC62304, ISO14971, IEC60601)
Make a substantial contribution to ways of combining Agile with medical software development
Able to develop own competences further, assesses which aspects require further research and works out the form this should take
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs).
These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
The business you will support is the Connected Digital Platforms and Propositions. Our user-centered connected propositions contain re-usable components, within an increasingly open ecosystem. They also use current connectivity standards and cloud services. In short, they empower people. This team of which you’ll be a part helps deliver best-in-class, end-to-end solutions. These include connected hardware, appliances, medical devices and wearables, and leading mobile apps across all major OS platforms. The team also develops various back-end cloud systems that integrate with these propositions.
The team works according to Agile principles, following SAFe (Scaled Agile Framework) processes. You will work on highly innovative, first-of-their-kind propositions that are new within Philips, so an entrepreneurial mindset is an advantage. Together with your team, you will strive for continuous improvement of deliverables, your way of working and yourself. The world doesn’t run from 9 to 5, so flexible working hours can be combined with a healthy work-life balance. Colleagues will challenge and coach you and you should willingly return the favor.
We offer the opportunity to play a leading role in achieving Philips' ambitions with digital connected products and to truly contribute to the way our innovations improve the health and well-being of our customers. You will work in close cooperation with global teams across Philips, playing a key role in driving the transition process that will turn Philips into a Digital Systems company. We invite you to be part of a challenging, innovative environment with great opportunities for personal development.
Our benefits are very competitive and designed around your preferences:
A competitive salary offer depending on your experiences
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
We are looking for
Bachelor’s engineering or science degree
Minimum of 10 years’ experience in (networked) product design and development, with exposure to regulated products
At least 3 years’ experience acting in a quality role and with focus on software;
Excellent understanding of working according standards and regulations, in particular related to US and EU medical
Device regulations and ISO (21 CFR 820, MDD, ISO13485, ISO14971, ISO9001)
Proven track record with development methodologies like Agile/Scrum/V-Model
Preferably you are a Certified Quality Engineer (ASQ) or possess a Green Belt certification;
Working knowledge with the IEC62304 standard is preferred
Strong interpersonal and influencing skills as well as analytical/Statistical skills
Experience with working in 10+ person multidisciplinary teams
This role will appeal to you if...
Enjoy working in cross-functional teams
Are curious, open and feel at home in an international environment
Have an affinity with innovative development projects and feel comfortable with relatively vague requirements
If you’re interested in this opportunity to join us, please apply through www.philips.com/careers using job id. 199298 or the "apply' button.
In case of any questions you can contact the responsible Talent Acquisition Consultant: Koen Meewis (email@example.com ).
After a pre-selection process based on your CV, you will be invited for face-to-face recruitment- and business interviews at High Tech Campus (Eindhoven - Netherlands).