Vacature detailsLocatie: Wilnis
Riet van Oostveen
Quality Specialist in Medical Devices - Van Oostveen Medical B.V.08 november 2018
We offer a position for an experienced Quality Specialist in Medical Devices (13485). The Quality Specialist performs the preparation, coordination and execution of internal audits in the offce/warehouse of Van Oostveen Medical – Romed Holland (www.romed.nl) as well as update/completion of technical files. In this role you are responsible to analyze internal audit results and quality/compliance risks for management reporting, as well as registration of medical devices. You will support the teams to develop corrective and preventive actions, and will track on-time completion and effectiveness of the actions. You may support the development of audit tools, and training programs to increase employee awareness and knowledge of compliance policies, and interpretation of regulatory requirements. You may support external inspections, including providing response to inspection observations and follow-up on actions.
- University degree or HBO (in (biomedical) engineering, health sciences, (medical) biology or quality management)
- 2+ years relevant work experience in medical clinical auditing and preparation of Technical Files according to MDD 93/42EEC
- Knowledge of Quality Systems standards (ISO ISO9001, ISO 13485) and the new MDR regulations.
- Fluent written and spoken English
- Products certi cation and regulatory strategies;
- Risk management for projects, products and processes
- Management Systems (ISO13485, ISO 9001 and CE Mark)
- Training of teams and individuals;
- Audits and inspections.
- Work in MKB health care company
- Good working conditions
- Full responsibility for Quality control
From our Dutch offices we serve customers in more than 50 countries worldwide. We have branch offices and distributors in Europe and elsewhere. We have been in the business for over 30 years now, selling medical disposables and medical devices. Our organization has acquired a substantial pool of experience and knowledge,
which we make available to our customers all over the world.
We believe that excellent performance must be backed by personal commitment and attention to all customers needs. This has helped us to become a leading supplier of medical disposables and devices. We constantly need to improve by proving our quality. We realize that our success completely depends on continuous
support and confidence of our factories and customers.
We are aware that we are players in a highly price-competitive market. What we aim to do, is to supply the right product at the right price from stock or with short delivery times. All our products have CE Certi cates and can be sold across Europe after registration with governments in specific countries. Our warehouse facilities and product handling procedures comply with international requirements and we are inspected regularly by notified bodies and by customers. All Romed products are registered in Holland. We also sell to Dutch hospitals and to pharmaceutical wholesalers. All our products are kept in stock.
Van Oostveen Medical B.V. | Romed - Holland | Herenweg 269 | 3648 CH Wilnis | firstname.lastname@example.org | www.romed.nl