Good working conditions
Quality & Safety
Detachering via YER
Medical & Health
Over deze vacature
YER is looking for an experienced Quality Engineer Medical Devices. Do you believe that technology can make a big impact on business and society? Are you driven by getting the best out of yourself and your team? Do you know like no other what Quality Assurance should look like? Are you still interested? Please continue reading.
We are looking for an innovation maker with in-depth knowledge of quality processes as well as a broad experience with medical device product development. You will be involved in the most exciting projects, focused on improving the product and process quality for medical devices.
- Participate in creating solutions to complex problems for our clients in the Life Science sector and ensure an efficient regulatory compliance for sustainable access.
- Implement or ensure a compliant Quality System that is adapted to the business needs and site specifications, and keep it up-to-date with regulatory upgrades all times;
- Support of the whole life cycle for medical devices (21 CFR 820 & ISO 13485);
- Involved in the most exciting projects in which you will expand your expertise by working closely with our clients to really make innovation matter.
- Getting involved with safety, regulatory compliance.
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 employed by YER and seconded to Philips. We offer:
- Good employee benefits;
- Excellent guidance from your consultant and YER's back office;
- Cooperative and results and relationship-driven;
- 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.
- Bachelor or Master degree in (Bio)Medical Engineering, Electrical Engineering, or equivalent.
- Proven background in a Manufacturing/Production or Product development environment;
- Experience working with quality and reliability tools and templates, e.g. Minitab, FMEA, FTA, HAZOP;
- Perform by a unique end-to-end approach combining technology, usage and verification & validation;
- Familiar with relevant regulations and standards (e.g. EU MDD, FDA, ISO 13485, );
- Good knowledge of management structure (ISO certified) providing continuous and effective support and training programmes, pooling and sharing knowledge and experience, as well as industry-specific best practices and benchmarks is an absolute plus;
- Strong verbal and writing skills in English;
- knowledge of Quality Assurance and also a broad knowledge of Quality Systems (Quality Audit and Quality Systems optimisation), Operational Quality Assurance, Quality Control, Qualification & Validation, Quality coaching & training and Quality & compliance management tools.
- A team player, enthusiastic, client and goal oriented, ambitious and ready to take on a challenge;
- You can adapt easily in new environments and have developed organisational sensitivity;
- You have a creative mind and like to develop yourself more in skills and knowledge by training and coaching and working on innovative, technically challenging and complex projects;
- You can see the bigger picture, have a strong analytical mind and approach challenges from a practical standpoint;
- You are flexible and can communicate on different levels