Quality Assurance

il y a 4 jours

Brussels, Belgique Covartim Temps plein

**A 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. 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);
- 6 managers leading the team but also working on the projects: Emilie, Aurore, Eléonore, 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 or Liège 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 and in Liège. 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 Manager, you will join the QA/RA team that includes 6 people and that is led by Aurore.

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).

**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 cosmopolitan team;
- Make clients' satisfaction a priority by combining quality and professionalism;
- Driving license

**Required seniority level**

We are looking for people with a proven experience in order to make our clients and colleagues benefit from an advanced expertise. You will get introduced to our methods then you will take the full lead on challenging projects.

**Still you can develop your skills and grow within COVARTIM**

Once a year you will define your goals with your manager. It will be a good opportunity to discuss your expectations and needs in terms of responsabilities and training as well as your salary. After 6 months your manager will make sure that you are on the right track to achieve your targets and that your expectations have not changed. Based on the level of your autonomy, your control and your skills you will have the chance to grow within your team and/or the company itself; get more responsabilities in people management or become an internal reference on a specific technical topic (we call them our Yoda's).

**Homeworking**

We know that homeworking is a must nowadays. However when several people work on the same project the office remains the best option for interactions, ideas and pieces of advice sharing. Same for the coaching which is essential during the first months.

**Offer**:
**Salar

  • Quality Assurance Manager

    il y a 2 jours

    Brussels, Belgique HNM Solutions Temps plein

    **Job ID: HNMJD3415**: **Role: Quality Assurance Manager** **Location: Brussels, Belgium** **Language: English** **Description of the task**: - The Following tasks will be performed by an external service provider: - Elaboration and maintenance of IS quality control procedures. - Provision of quality plans and service level agreements. - IS Quality...

  • Quality Assurance Consultant

    il y a 4 semaines

    Brussels, Belgique PharmEng Technology Temps plein

    **Job Summary**: The Quality Assurance Consultant is responsible for the implementation, maintenance, and oversight of the Quality Management System (QMS) in local affiliates. This role ensures compliance with regulatory requirements, quality standards, and company policies. The Quality Assurance Consultant will manage quality risk, complaints, change...

  • Quality Assurance Specialist

    il y a 3 jours

    Brussels, Belgique Nestle Temps plein

    **Position Summary**: Nestlé is the world's largest food producer, and this is built on consumer appreciation and trust. As our Quality Assurance Specialist your job is to reinforce and protect our quality reputation and values. You ensure our Dutch and Belgian organizations adhere to the highest standards. You combine knowledge of management systems that...

  • Quality Assurance

    il y a 1 semaine

    Brussels, Belgique EMVO (European Medicines Verification Organisation) Temps plein

    **Function**: As our **Quality Assurance Expert**, you will report to the **Quality Assurance Manager** and be playing a vital role in: - Maintaining and supporting the **Quality Management System, **and ensuring** **EMVO’s **owned systems and services’** compliance**: - **You will be the Quality Assurance SPOC **for assigned systems/processes - You...

  • Quality Assurance Manager

    il y a 1 semaine

    Brussels, Belgique Unisystems Temps plein

    Elaboration and maintenance of IS quality control procedures - Definition, elaboration, management and participation of quality tests. - Participate in Test case automation, write automated tests - Coordination and collaboration with the project teams. Participate in Sprint Review meetings. - Support the Project Managers of information systems to meet...

  • Quality Assurance

    il y a 1 semaine

    Brussels, Belgique EMVO (European Medicines Verification Organisation) Temps plein

    **Function**: As Quality Assurance (QA) Expert, you will be responsible for: - Maintaining and supporting the **Quality Management System, **and ensuring** **EMVO’s **owned systems and services’** compliance**: - Reporting to the** Quality Assurance Manager**: - **QA SPOC **for assigned systems/processes - Supporting the QA review of **Change...

  • Quality Assurance Manager

    il y a 2 semaines

    Brussels Metropolitan Area, Belgique ACENSI Temps plein

    ACENSI is looking for a Senior Quality Assurance Manager :Will you help us change the world? Our client is a fully independent gas infrastructure group with 1,200 employees active in gas transmission & storage and liquefied natural gas terminalling, not only in Belgium but also with affiliates in Germany, France, U.K., Switzerland…. As a purpose-led...

  • Quality Assurance Manager

    il y a 5 jours

    Brussels Metropolitan Area, Belgique NEBIRU Temps plein

    Lead Quality AssuranceAre you ready to play a crucial role in our client's transition? A leading player is searching for a Senior Test & Quality Assurance Manager to ensure the highest standards in its digital transformation projectsYour Impact:Define and implement a robust test strategy to guarantee high-quality digital solutions.Oversee and challenge...

  • Quality Assurance Manager

    il y a 3 semaines

    Brussels, Belgique Colas Temps plein

    **Wie zoeken we?**: Binnen Colas Belgium streven we naar de hoogste kwaliteitsnormen en zijn we op zoek naar een ervaren Quality Assurance Manager om ons team te versterken. **Functieomschrijving**: Als Quality Assurance Manager ben je verantwoordelijk voor het onderhouden van ons kwaliteitmanagementssysteem en het uitvoeren van interne audits. Je werkt...

  • Product Quality Assurance Officer

    il y a 5 jours

    Brussels, Belgique feneko Temps plein

    Feneko als werkgever? FenekO Group is een commercieel partnerschap tussen verschillende Belgische producenten van bouwmaterialen in gelakt of bekleed aluminium. Onze unieke "one-stop-shop" ervaring laat elke professionele schrijnwerker toe de nodige accessoires te bestellen voor de totaalafwerking van een residentiële gevel, van vliegenramen en...

  • Quality Assurance Officer

    il y a 3 semaines

    Brussels, Belgique STADA Arzneimittel AG Temps plein

    **About EG** - EG is a Purpose driven company: at the core of everything we do, we aim to Care for People´s Health as a Trusted Partner.- EG is the largest pharmaceutical company in Belgium.- With an offering for just about every therapeutic area, we are the market leader in generic medicines and the biggest OTC company in Belgian pharmacies.- Most of our...

  • Product Quality Assurance Officer

    il y a 2 semaines

    Brussels, Belgique HAYS Temps plein

    Brussels | Product Quality Assurance Officer | Aluminium sector | Voltijds | NL- FR -EN | 1096128 **Over de organisatie** *** Onze klant, een dynamische kmo actief in de **aluminiumsector**, telt 140 werknemers. Het bedrijf zet zich elke dag in voor het verbeteren en optimaliseren van haar producten en processen. Daardoor kunnen ze producten van hoge...

  • Senior Specialist Quality Assurance

    il y a 4 jours

    Brussels, Belgique Organon Temps plein

    For our Distribution & Supply Chain Quality team we are currently recruiting for the role of **Senior Specialist Quality Assurance - Supply Chain Hub 3PL Quality Oversight**. **Purpose of the role** In the role of Senior Specialist Quality Assurance - Supply Chain Hub 3PL Quality Oversight you will manage the collaboration and relation with our regional...

  • Bordet-ctsu: Quality Assurance Officer

    il y a 4 semaines

    Brussels, Belgique Hôpital Universitaire de Bruxelles (HUB) Temps plein

    **Fonction**: The Institut Jules Bordet is an integrated multi-disciplinary centre, unique in Belgium and with an international reputation. The hospital is an academic non-for-profit organisation devoted entirely to patients affected by cancer. The Clinical Trials Support Unit (CTSU) is a department of the Institut Jules Bordet and fights cancer through the...

  • Quality Assurance

    il y a 4 jours

    Brussels, Belgique The White Team Temps plein

    **PROJECT MANAGER POSITION IN BRUSSELS_EUROPEAN COMISSION** IT Project Management to provide advice, guidance, consultancy and assistance to the responsible official(s) in regard to the management of outsourced IT systems: - ART2: programme management system - PICS: collaboration space for taxation and customs communities - LMS: Learning Management System...

  • Quality Assurance

    il y a 3 semaines

    Brussels, Belgique Systems Accountants Temps plein

    Quality Assurance - IBM Planning Analytics Expert (TM1), BrusselsLocation: BrusselsJob Category: Information TechnologyEU work permit required: YesJob Reference: J19489_1734360822Job Views: 20Posted: 16.12.2024Expiry Date: 30.01.2025Job Description:The Quality Assurance Specialist is responsible for ensuring the quality and reliability of the IBM Planning...

  • Bordet-ijb-ctsu: Quality Assurance Officer

    il y a 4 jours

    Brussels, Belgique Hôpital Erasme Temps plein

    **Fonction**: The Institut Jules Bordet is an integrated multi-disciplinary centre, unique in Belgium and with an international reputation. The hospital is an academic non-for-profit organisation devoted entirely to patients affected by cancer. The Clinical Trials Support Unit (CTSU) is a department of the Institut Jules Bordet and fights cancer through the...

  • Solution Architect

    il y a 7 jours

    Brussels, Belgique Tobania Temps plein

    **What can you expect?**: Our Software Testers have been breaking new ground in **Quality Assurance in Agile/DevOps environments **since 2016. We are looking for a Solution Architect who wants to help set out our future course, strengthen our team and build the best solutions for our customers. **What do Solutions Architects do at Tobania?** - **You are the...

  • Sterility Assurance Manager

    il y a 6 jours

    Brussels, Belgique Catalent Temps plein

    **Job Description Summary** Management of relationship with Global Functions and external network (ASCCA, PDA, ISO, Pharmaindustria, Other Pharmaceutical Companies); Definition of Quality Strategies for Aseptic Production in collaboration with Project Teams, Production/MT/Engeneering/Validation/Quality Departments Implement Innovation related to Sterility...

  • Quality Assurance

    il y a 6 jours

    Brussels, Belgique Penguin Formula Temps plein

    Company Description We Cook iT is an international software house that delivers software development to its corporate customers by providing highly skilled, communicative IT professionals to build their customized products through outsourcing, nearshoring and turn-key projects’ solutions. How do we differentiate ourselves? By investing in the...