In this role, you have the opportunity to
guide and support Cardiology informatics (CI) Business 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 & services that deliver high quality and outstanding reliability to the lives they will improve. Cardiology Informatics is a fast growing global business line within Healthcare Informatics with the ambition of doubling the business by 2020.
You are responsible for
Supporting the business Q&R lead to implement the Business’ long-range quality, regulatory and compliance policy.
Creating quality and regulatory awareness in the organization.
Managing compliance of the Quality Management System (QMS) to regulations, standards, guidelines and policies and support the deployment of the QMS. Special focus is currently given to the implementation of the new Medical Device Regulations of the European Union
Leading the maintenance and further development of the quality management system in line with harmonized Philips quality management systems.
Introducing and implementing the quality processes and tools required to ensure product quality and customer satisfaction.
Managing and monitoring CAPA process.
Contributing in the successful completion of internal and external audit program.
You are a part of
a fast-growing business that help improve the lives of millions of people, while advancing Philips digital transformation journey as a global leader in Health Technology. You will help reach Philip’s ‘quadruple aim’: enhancing the patient experience, improving health outcomes, lowering the cost of care, and improving the work life of care providers. Cardiology Informatics develops software solutions which are at the heart of Philips innovative ambition and ‘quadruple aim’. Associated locations and team members you will closely work with are located in The Netherlands, Brazil and Northern Ireland. It is an additional challenge to work in such diverse cultural environment – but very exiting at the same time.
To succeed in this role, you should have the following skills and experience
Bachelor/Master Degree in Informatics or other relevant science
3-10 years of total industry experience with at least 2 years of experience in medical device (preferred) or in other regulated industries like pharma, automotive or aerospace (required)
Experience with dealing with software development (Agile, Safe) is preferred
Good knowledge and experience with Quality Assurance & control methodologies (requirement)
You have experience in Regulatory Affairs; interpreting regulations and standards and bringing these into practice
Excellent verbal and written communication skills in English
Working knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, FDA QSR, EU MDD
Experience in writing Quality Management System procedures, maintaining and training them.
Self-directed with a strong work ethic, with an ability to work in a goal-oriented environment.
Somebody able to lead a cooperative effort among members of a project team
An ability to work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
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 .