In this role, you have the opportunity to
Increase and ensure the compliance level, concerning Quality System relevant Software (SW) Validation with the Philips Market organization. As Software Engineer you will part of a Philips Quality Management System team of 25 people and support the Market Quality & Regulatory organizations within Philips. You will do the daily management of 4 people (about 15% of your time). Next to this you will be responsible for the Software Validation and stakeholder management towards the different Quality & Regulatory organizations within Philips.
You are responsible for
Executing and /or managing SW validation & control activities
Ensuring that new software and changes to existing software or infrastructures are validated before approval and use
Ensuring the accuracy, completeness and compliance of SW validation deliverables by reviewing the SW validation packages of SW applications which automate Quality System processes
Authoring, reviewing and/or approving SW validation deliverables for non-product SW, including but not limited to SW validation plans, requirements, test plans/protocols/results, risk assessments, traceability matrix and summary reports
Acting as team lead for the Market Central Software Validation team and manages operational objectives and work plans
Supporting management and standardization of QMS processes in scope to ensure effective and compliant QMS. Drive deployment of Non Product System Software Validation process in the local Quality Management System, ensuring local and cross business harmonization, standardization and regulatory compliance
Managing escalations to IT, CoE Software Validation and Businesses for correct allocation and listing of Market NPSS’s.
Managing and continues improving compliance to ISO 13485, EU MDR, FDA regulations and other Regulatory Agencies as required, including management of leading and lacking KPI’s for Software Validation, Management Review input, support of external and internal audit and follow-up of subsequent actions.
Acting as Business process expert for processes in scope, providing training and acting in support of the local Market organizations and the PQMS leader and QMS element owners across the markets to deploy harmonized and standardized Philips processes
To succeed in this role, you should have the following skills and experience
Bachelor’s degree with at least 7 years of experience of which at least 3 years of related experience in the medical device, automotive, aerospace, pharma or defense.
Experienced with IT software applications development and SDLC methodologies from requirements to validation (based on SDLC (Software Development Life Cycle))
Experience in supervision of a team of 2-5 people
Strong background in FDA, ISO and EU regulations for medical devices and healthcare; especially FDA 21CFR Part 820/Part 11, ISO 13485 and EU Annex 1 (highly preferred)
An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
Demonstrated capability in critical thinking and leadership with strong abilities in relationship management and proven experience in escalation management to senior leaders within local and/or global organization
Effective judgement and decision making skills, typically made under stressful situations
Project Management (development of project plans, status meetings, project reporting, etc.) and organizational change management;
Communication in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor
You are a part of
The PQMS Markets Central Team plans, controls and manages relevant QMS activities for all 17 Markets worldwide within Philips. This includes Personal Health, Sleep and Respiratory Care, Diagnosis and Treatment, and Connected Care and Health Informatics and Customer Services. The core business of the Markets is the Sales, Marketing, Distribution, Installation and Servicing of Philips medical and non-medical devices and solutions designed & manufactured by the Business Units.
The PQMS Markets Central team consist of 25 QMS professionals mainly based in Eindhoven, the Netherlands. You will be reporting directly to the Head of PQMS Markets.
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 at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .
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 .