Quality Assurance
Il y a 7 mois
**Super-hero working for the compliance of medical devices**
- ISO 13485, 21 CFR, 510(k), MDR 2017/745, IVDR 2017/746_ mean more than a series of numbers and letters for you?
Working on several projects in parallel does not scare you? But, on the contrary, you are looking for a varied job?
Knowing that your job can have an impact on people's health gets you motivated to wake up every morning?
Then you cannot miss this job ad
**Who we are?**
COVARTIM is an engineering company located in Brussels. Our mission is to help the MedTech industry foster medical innovation and improve health care.
More concrete we support any kind of organisation (practitioners, startups, SMEs, big companies) in the development and the certification of their medical technologies.
**In a nutshell**:
- Launched in 2016 by Kyun, Founder and Director, passionate about medical technologies and working in the field for more than 15 years;
- A (small) team of 15 people (24-52 years old) always ready to help each other (and play table football);
- 4 managers leading the team but also working on the projects: Emilie, Arnaud, Laurent and Kyun;
- 40+ projects in parallel every month;
- 100+ clients in BeNeLux, France, USA, Japan, Finland,
In order to answer the constantly growing demand from current and future clients, we are looking for additional members for our team _Quality Assurance & Regulatory Affairs_.
The job is located in Brussels for an open-ended period, to be filled immediately.
Ready ?
**Practically, what will you do?**
Your mission will be to:
- Implement Quality Management Systems at our clients, based on the one we have developed;
- Perform internal and external audits at our clients;
- Develop regulatory strategies for the introduction of innovative medical devices on the market;
- Review and prepare documentation for Notified Bodies, FDA and the competent authorities;
- Provide our clients with operational support (hands-on);
- Perform regulatory watch and gap analysis to make sure we are still best-in-class.
**How ?**
We perform projects for our clients in our office in Brussels. We go to our clients' premises for kick-off and follow-up meetings and for audits. Some clients want to see us once a week, others are located at thousands km from Brussels and only see us on Teams. This means that we spend most of our time at the office, together with the team.
**What about the team ?**
Our members are gathered in two teams : the _Development_ team and the _Quality Assurance & Regulatory Affairs (QA/RA) _team. As a QA/RA Officer, you will join the QA/RA team that includes 4 people and that is led by Arnaud.
The mission of the QA/RA team is to help our clients achieve the compliance of their devices with regards to the regulatory framework and to provide support for the introduction on the market.
**Examples of projects**:
- Development of the US regulatory strategy for a software (Class IIa);
- Support to solve non-conformities after an audit on biocompatibility and packaging and to achieve CE mark for orthopaedic implant and instruments (Class III);
- Implementation of a QMS and support with the certification of a monitoring software (Class IIa);
- Support with the regulatory analysis, QMS implementation and certification (Class C).
**About your future manager**:
Arnaud is French and trained as a pharmacist. Before joining us in 2017, he worked for 4 years at a medical devices manufacturer as RA Officer. Arnaud started his career at COVARTIM as (unique) QA/RA Manager and he quicky got new responsibilities. Today he leads the QA/RA team by ensuring the follow-up of the projects, by helping his teammates with their tasks and by making sure they all feel well.
In addition, Arnaud works on projects too; he implements QMS, performs audits at our clients and gives trainings.
What he likes the most? Our human-size and the atmosphere (cohesion, work environment, balance work/life and the after-works).
**Every profile is welcome**
You start your career? Our team will be there to guide you You will collaborate on several projects and you will quickly have an overview of what can be done here. Cherry on top: you will learn and discover a lot in a short time
You have got a first experience already? We will support you in the development and the enhancement of your knowledge and know-how. You will become more and more autonomous, take the lead on your projects and coordinate team work.
You have got a proven experience? We will be happy to make our clients and colleagues benefit from your expertise You will get introduced to our methods then you will take the full lead on challenging projects.
**In order to fulfill your mission, you will need**:
- Good understanding of Medical Devices and IVD regulatory environment (directives, regulations);
- Good knowledge of Medical Devices quality assurance (ISO 13485, 21 CFR) and relevant standards;
- Speak French/Dutch and English to communicate with our clients and our co
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