Philips QMS Manager in Eindhoven, Netherlands
· Support site Q&R lead to implement the Business’ long-range quality, regulatory and compliance policy
· Create Q&R awareness level as determined within the organization.
· Enforces (a simplified) quality systems and harmonizes them across the Business
· Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction.
· Manage compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.
· Manages the review and approval of finished products developed for and by the company in accordance with their approved specifications.
· Ensures training- & competence management in line with PQMS requirements.
· Manage and monitor CAPA process
In this role, you have the opportunity to
Guide and support Cardiology informatics Business (CI) 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.
You are responsible for
Supporting site Q&R lead to implement the Business’ long-range quality, regulatory and compliance policy;
Creating Q&R awareness level as determined within the organization;
Enforcing (a simplified) quality systems and harmonizing them across the Business;
Introducing and implementing the quality processes and tools required to ensure product quality and customer satisfaction;
Managing compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations;
Managing the review and approval of finished products developed for and by the company in accordance with their approved specifications;
Ensuring training- & competence management in line with PQMS requirements;
Managing and monitoring CAPA process.
You are a part of
Philips Healthcare Solutions & Services (HISS)/ CI belongs to the most innovative Business in Royal Philips.
Associated locations and team members you will closely work with are located in USA, Germany, India and Netherlands. 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;
3-5 years of total industry experience with at least 2 years of related experience in a medical device or other regulated industry is required;
Knowledge of FDA QSR, ISO 13485, ISO 14971 and related relevant regulations and standards;
Working knowledge of appropriate global medical device regulations or other regulated industry, requirements and standards is required;
Expertise/experience in root cause analysis, corrective/preventive action methods and problem solving with quality tools such as: 6-sigma / 8-D / CAPA / FMEA/ 5WHY etc.;
Very good communication and documentation skills;
Fluent in English; speaking, reading and writing;
Proactive, independent, target oriented and self-motivated.
In return, we offer you
A challenging, innovative environment with great opportunities for you to explore. Furthermore, our benefits are very competitive and designed around your preferences.
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 .