QA/RA Manager
Description:
Are you an experienced QA/RA manager in the field of medical technology, but do you miss the challenge of being involved with innovative products that make a real difference? In addition, do you like working in a growing SME and collaborating with colleagues, suppliers, and customers worldwide? Then contact us now!
We are looking for an experienced QA/RA manager to manage the existing quality and information security management system for our processes and the products that we sell internationally. A new facet will be added in 2024 which involves developing and selling medical products. As QA/RA manager, you will play a crucial role in gaining and retaining the appropriate certifications and clearance that will allow us to sell our products in various international markets.
What are your responsibilities as QA/RA manager?
- Managing the existing quality and information security management system in accordance with ISO 9001, ISO 13485, and ISO 27001.
- Managing the integration of the quality management system into business processes in accordance with MDR and FDA legislation for medical products.
- Safeguarding quality within processes and products by cultivating awareness and performing risk analyses as well as internal and external audits on processes and products.
- Compiling and executing policy in the field of health, safety, and the environment, which includes performing a risk inventory and evaluation (RI&E).
- Setting up and expanding the QA/RA team, which includes supervising and developing a yet-to-be-appointed junior QA/RA engineer.
What is needed for the job of QA/RA manager?
For this position, we require you to be educated to at least HBO/WO (college/university) level and to have minimum 3 to 5 years’ experience in managing quality and information security management systems and obtaining the appropriate certification and clearance for medical products.
Furthermore:
- You must have good communication skills and be able to clearly present your ideas and views and to defend them without wavering.
- You must be curious and open to new developments.
- You must be able to speak and write Dutch as well as English.
What ZiuZ offers
ZiuZ offers a 40-hour working week and a good package of employment conditions, which includes a pension premium on top of the basic salary, a travel allowance, a standard expenses allowance for e.g. internet facilities at home, and an allowance for a mobile-phone subscription. ZiuZ also offers 27 leave days per year as well as a hybrid way of working, which means it is possible for employees to partly work from home and partly from the office.
We acknowledge the importance of personal development and therefore offer a personal training budget. Besides your daily tasks, there will also be room for informal contact with your colleagues. This is possible during the collective coffee breaks, during the lunch served by ZiuZ, and during sports activities that are organized fortnightly, but also during fun activities like a game event, a mountain bike ride, or a family day.
Would you like to know more about this position or our organization? Then please get in touch with us! We will gladly offer you further information, although you can also visit our vacancies page at jobs.ziuz.com.
Acquisition in response to this vacancy is not appreciated.
