Max. € 80,000
Quality & Safety
Detachering via YER
Over deze vacature
We are looking for a QMS Manager who will manage the transition process to one specific QMS, by means of Quality planning.
Implement changes in the QMS related to:
- Philips level PQMS standards, procedures and end-to-end projects
- Regulations: EU MDR, ISO13485:2016, FDA QSR, Chinese FDA etc.
- Keeping the integrity of the QMS is an important requirement while implementing changes
- CAPA: Act as CAPA owner for implementation of QMS Manager owned CAPA’s
- Audits: Act as owner of resolution of findings of QMS Manager owned Audit findings
- Improve way of working of the QMS team using LEAN methodology
- Provides training for relevant QMS Management areas
- Reports to the QMS Manager (team lead)
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.
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
- Several years’ experience in (a minimum of 3 years) of similar work experience in a medical device regulated environment
- Experience on working in disciplined regulated industry and in applying automated technology
- Experience with validating activities
- Experience with business implementation projects, including being an active contributor on projects with scheduled deliverables
- Demonstrated ability to understand and develop processes
- Demonstrated ability to interact and communicate in English, including demonstrable writing, speaking, and comprehension skills
- Ability to communicate across all levels in the organization