Tot € 80,000
Detachering via YER
Over deze vacature
Provide compliance and quality management system process improvement support to the E2E Program teams to ensure compliance with optimization and efficiency in E2E processes.
Quality Assurance is an integral aspect of the global healthcare business including device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance. This position is intimately involved in the process of ensuring quality system regulations are embedded within business processes and supports the harmonization of identified key processes by which the company and its sectors operate.
Your main responsibilities are:
- Quality management system business process expert, acting to support for the Philips Healthcare quality assurance team and as a Q&R business process owner, across the Philips Q&R network for the E2E program
- Participate directly as the Philips Healthcare quality management system business process expert in Philips “process capabilities” deployment programs, in the idea to market (I2M), market to order (M2O), and/or order to cash (O2C) arenas. Ensuring compliance, efficiency and effectiveness of the processes within the Philips Healthcare sector, cross sectors, and at Philips corporate
- This entails a thorough knowledge, as example, of design (I2M), marketing & brand & promotions (M2O), production & servicing (O2C) and procurement/purchasing
- Includes, but is not limited to all idea to market (I2M), market to order (M2O), and/or order to cash (O2C) processes
- Support cross-Philips setup and deployment of the quality management systems along business model lines as identified by end to end teams through the creation of quality transition plan(s) that identifies appropriate Q&R activities to ensure compliance
- Work with Philips end to end & ARIS process modelling teams, business management system and quality management system owners, as well as any other stakeholders to ensure new process descriptions and procedures (PDDs – process definition documents) are efficient, effective, and compliant to the applicable regulations
- Work with Philips Software validation teams to ensure fully integrated, validated and compliant Philips integrated landscape (PIL) software application are deployed
With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision making.
You will be part of the Q&R team that consists of approximately 40 team members who are working for the businesses- Mother & Child Care, Skin Care, Health Measuring Devices & Pain Relief reporting to the QAM Group lead. You will be based in Eindhoven, The Netherlands. You will work in project teams with co-ordination with marketing teams, manufacturing teams at various sites, supplier teams, and other Q&R members across Philips.
We welcome you to a challenging, innovative environment with great opportunities for you to explore. YER is preferred supplier. You will be employed by YER and seconded to Philips.
Our benefits are very competitive and designed around your preferences:
- A competitive salary depending on experience
- Extensive set of tools to drive your career, such as a personal development budget, training and coaching
- Healthy work-life balance
We are looking for:
- Bachelor’s degree, preferably in a scientific discipline
- Minimum of 7 years of experience working in Quality Assurance/Quality Engineering/Quality Systems supporting multiple functional disciplines within a global medical device industry
- Proven experience in quality management system processes, including cross sector or business process standardization, ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations
- A comprehensive understanding of the diverse worldwide medical device quality regulations, including areas of device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance
- An ability to successfully communicate and educate quality management system regulations, policies and strategies to teams at all levels of the organization
- Experience with deployment of quality management system processes as identified
- This position requires extensive knowledge of FDA QSR’s, ISO 13485, JPAL, China GMP’s and other worldwide Quality System Regulations