Quality manager
Functieomschrijving
At cTechnology we are looking for a Quality Engineer who is responsible for the implementation and maintenance of several standards, like ISO 13485, ISO 14971, ISO 62366, ISO 62304, 21 CFR part 820 and EN60601/1/x. As a quality Engineer you will have to communicate and interact regularly with the design & development, production and service teams. You will also train new people in the company to ISO 13485.
Furthermore, you will have some customer related responsibilities, as taking care of customer complaints, external audits and unannounced audits. Finally you will keep an eye on the full life cycle of current and newly developed products and whether they are in accordance to the standards or not. You are the management representative for notified bodies.
Profiel
- Master degree
- Preferably 5-10 years of experience in healthcare industry, preferably in QA & in the medical devices industry
- Expertise in ISO 13485, 21 CFR part 820 and ISO 14971, ISO 62366 as well as knowledge on technical standards, e.g. ISO 62304 and EN60601/1/x
- Regulation EU 2017/745 on medical devices
- Fluently in Dutch and English, both orally and writing
- Driver licence type B
- You work highly accurate and you are achievement - & customer service orientated.
Aanbod
Waegener: A personal approach on every level
At Waegener, we believe that health-care is a means towards well-being. Our mission is to create innovative applications that enable both patients and medical professionals to optimize the recovery process. Our applications have a proven efficiency. We invest a great deal in R&D and work with protocolled standards only.
Every person is different and everyone recovers in a different way. In everything we do, we focus on the person behind the injury. So that ultimately, our work results in a better well-being of patients.
Our innovative and patient specific approach in health-care demands the daily commitment of an ambitious and dedicated multidisciplinary team of professionals, all aspiring to the highest standards. Every department within Waegener works closely together, so that all developments are easily implemented throughout the company, in line with our values. You will be part of a very dynamic, young and growing team in a highly innovative environment.
Last but not least, you will have freedom to shape your work and shape your job. Your input is highly appreciated.
van