SYSTEM NORM COMPLIANCE EXPERT
Functie System Norm Compliance expert
identification and verification of quality and regulatory product requirements in accordance to Quality & Regulatory demands set forth in regulations, directives, standards, guidelines, and common specifications.
being the interlinking pin between System Architects, product development engineers and Regulatory Affairs deploying and implementing regulatory product requirements to ensure creation of compliant products and compliant product documentation.
working closely with product development teams within Philips business units as well as external customers driving product quality and compliance. This includes, but is not limited to, support the creation of regulatory plans, perform safety and risk assessments, facilitating U-D-P-FMEA's and product verification reporting to effectively assure product quality and to mitigate potential compliance risks.
supporting ES business portfolio by defining and implementing basic QMS for external new ventures (start-ups). This to strengthen the "license to operate" within the venture's field of expertise and to ensure compliance of the (technical) development work done by ES.
Driving quality and compliance in projects for the development of medical and non-medical devices, sub-assemblies, equipment, prototypes and investigational devices or other innovative Philips products by providing clear guidance during the implementation of applicable regulations including CE marking regulation, directives, standards and guidelines, to support best in class project execution and product realization.
acting as promotor for quality and regulatory awareness by supporting and providing training, instruction, and practical guidance.
support the implementation of the Philips âone way of working' in product development using and promoting PDLM.
addressing compliance deficiencies. Participating in product development, quality, and regulatory initiatives as a cross functional contributor.
supporting Engineering Solutions with the process of harmonizing Philips QMS's into one single PQMS structure.
providing support related to audit readiness for ES and its customers related to the ES projects conducted.
Over de werkgever
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.Wat wij bieden
You will be employed by YER and seconded to Philips. We offer:
- Good employee benefits
- Excellent guidance from your consultant and YER's back office
- Friendly atmosphere and open culture
- Community/network with other technology professionals from a variety of multinationals
- Events and master classes with interesting speakers and attractive companies
- Support the implementation of the Philips 'one way of working' in product development using and promoting PDLM.
- Addressing compliance deficiencies. Participating in product development, quality, and regulatory initiatives as a cross functional contributor.
- Supporting Engineering Solutions with the process of harmonizing Philips QMS's into one single PQMS structure.
- Providing support related to audit readiness for ES and its customers related to the ES projects conducted.
Er is geen minimale opleiding vereist