Philips Head of Product Quality Engineering - Software in Eindhoven, Netherlands
In this role, you have the opportunity to
Define, develop and implement organizational policies & standards to ensure safe and reliable products with a focus on software design; take up this highly visible and impactful position in the global Q&R organization of Royal Philips.
You are responsible for
Establishing a Process Quality Engineering practice with a focus on software design and V&V (validation & verification).
Establishing the policies/standards for quality and reliability performance of the Process Quality Engineering work in scope; the execution of the SW Quality Plan and any Risk Management activities, and of all design related activities during the software lifecycle.
Distinguishing by additional specialized knowledge in breadth and/or depth and act as the business partner and expert in the field of QA/QE and Software Quality. Potentially introducing new concepts.
Lead quality related problem solving for software and report on software performance in the field, initiate field action when needed.
Being a coach/mentor and single point of contact to a project team, ensuring that software design quality related requirements are completed, and meet software quality standards for every PDLM milestone.
Make a substantial contribution to ways of combining Agile with medical software development.
You are part of
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.
To succeed in this role, you should have the following skills and experience
Master’s Degree and a minimum of 10 years of industry experience from a highly regulated environment, preferably in medical device manufacturing
Strong leadership skills and demonstrated ability to influence change and challenge status quo with respect to opportunities for improvement
Expert knowledge and understanding and knowledge of principles, theories, and concepts relevant to Software Quality Engineering (e.g., CSQE body of knowledge), and expert level in requirement and configuration management including requirements flow down with different S/W development methodology – Agile/Scrum, V Model, etc.
Be a strong team player to collaborate with other QA/QE leads to establish the linkage between Risk Management (FMEAs), Reliability practices with V&V processes.
Ability to visualize problems at system level, understand system architecture and steer the team to work on the right focus areas.
Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169, and ISO 9001.
DMAIC, 8D, PRIDE and other problem solving, analytical skills and vast expertise in statistical techniques
In return, we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this market-based role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.
Why should you join Philips?
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .