QA / Ra Development Team Manager Medtech

il y a 7 jours


Bruxelles WatermaelBoitsfort, Belgique Walter Welton Temps plein

Our client is a Belgian engineering company specializing in the development of medical devices, IVD medical devices, and medical software. Based in Brussels, our client's focus extends to BeNeLux, France, and the US.

Founded in 2016, our client emerged with the aim of providing comprehensive solutions to entrepreneurs and SMEs, supporting them in bringing their medical innovations to market. Their expertise lies in Mechanical Engineering and spans various medical device sectors.

Passion for Medical Technologies fuels our client's team, consisting of individuals with expertise in the Medical Devices field. They actively engage in industry events, ensuring they remain close to the challenges and needs of the industry and its actors.

Our client is committed to fostering medical innovation and improving healthcare through their dedicated support of the MedTech industry.

Their goal is to contribute to advancements in patient care and the growth of the industry as a whole

This is your chance to work with innovative products and be part of something that will have a real impact in the Medical Devices industry.

**Responsibilities**:
The Development Team Manager is responsible for the daily operational follow-up of the company's Product Development Team, which is actively engaged in research and development activities for our clients. The key responsibilities include:

- Overseeing product design and prototyping processes.
- Preparing development plans and ensuring their successful execution.
- Coordinating industrialization and production activities.
- Planning and managing verification and validation (V&V) processes.
- Providing support for CE and FDA filing.
- Offering technical insights and project management support to the team.
- Coaching and guiding a team of four talented individuals.
- Managing own projects and serving as a direct interface with clients.
- Participating in the Management Committee and contributing to company strategy steering.
- Playing an important role in promoting the company's activities.

**Qualifications**:

- Minimum 8 years of relevant experience in medical device development.

**Hard Skills**:

- Excellent understanding of the medical devices regulatory environment.
- Proficiency in medical devices quality assurance (QMS) and relevant standards.
- Strong technical knowledge of prototyping, assembly, and manufacturing processes.
- Sound technical overview of medical device verification and validation testing.
- Fluent in English and French/Dutch.

**Soft Skills**:

- Passionate about Lifesciences, technology, and innovation.
- Strong focus on quality and customer service.
- Exceptional communication and organizational skills.
- Ability to work autonomously and quickly adapt to new situations.
- Flexible and open-minded approach.

**Offer & Benefits**:

- The opportunity to contribute to the development of products that improve or save people's lives.
- Full-time open-ended contract.
- Competitive salary package.
- Recognition and appreciation of your work.
- Pleasant working atmosphere.

Type d'emploi : Temps plein, CDI

Salaire : 5.000,00€ à 8.000,00€ par mois

Avantages:

- Aide au développement professionnel
- Aide au transport quotidien
- Assurance groupe
- Carte essence
- Chèques repas
- Éco-chèques
- Événements d'entreprise
- Formation continue
- Formations en entreprise
- GSM de fonction
- Indemnité kilométrique
- Indemnité kilométrique vélo
- Ordinateur de fonction
- Programme de bien-être
- Remboursement des frais de téléphone
- Remboursement des frais de voyage
- Remboursement internet
- Travail à domicile
- Voiture de société

Programmation:

- Lun-Ven
- Travail de jour

Types de primes et de gratifications:

- 13ème mois
- Bonus annuel
- Pécule de vacances
- Primes

Expérience:

- in medical device development: 6 ans (Exigé)
- Medical Devices: 4 ans (Exigé)
- Quality Assurance Medical Devices: 4 ans (Exigé)
- Regulatory Affairs Medical Devices: 4 ans (Exigé)
- Management: 5 ans (Exigé)
- Team People: 5 ans (Exigé)

Langue:

- Anglais (Exigé)

Lieu du poste : Télétravail hybride (1170 Brussels)


  • QA/ra Manager

    il y a 2 semaines


    Watermael-Boitsfort, Région de Bruxelles, Belgique Covartim Temps plein

    Functieomschrijving:The QA/RA Manager shall provide support for the development of innovative medical devices, as part of the COVARTIM QA/RA team.(S)he will manage Quality Assurance and Regulatory Affairs activities such as, but not limited to: Quality Management System implementation Standards watch and gap analysis Audits (internal/external) Review and...

  • QA/ra Associate

    il y a 2 semaines


    Watermael-Boitsfort, Région de Bruxelles, Belgique Covartim Temps plein

    Functieomschrijving:The QA/RA Associate shall provide support for the development of innovative medical devices, as part of the COVARTIM QA/RA team.(S)he will provide support in Quality Assurance and Regulatory Affairs activities such as, but not limited to: Quality Management System implementation at our clients site Standards watch and gap analysis Audits...


  • Watermael-Boitsfort, Région de Bruxelles, Belgique Walter Welton Temps plein

    Our client is a Belgian engineering company specializing in the development of medical devices, IVD medical devices, and medical software. Based in Brussels, our client's focus extends to BeNeLux, France, and the US.Founded in 2016, our client emerged with the aim of providing comprehensive solutions to entrepreneurs and SMEs, supporting them in bringing...

  • Ra/qa Officer

    il y a 2 semaines


    Bruxelles, Région de Bruxelles, Belgique Immunodiagnostics System Ltd Temps plein

    RA/QA Officer:QA/RA - Belgium:IDS is a leading in-vitro diagnostic solution provider to the clinical laboratory market. We develop, manufacture and market innovative immunoassays and automated immunoanalyser technologies to provide improved diagnostic outcomes for patients.The Liege site was founded as a spin off from the University of Liege in 1989 and now...

  • Ra/qa Officer

    il y a 2 semaines


    Bruxelles, Région de Bruxelles, Belgique Immunodiagnostics System Ltd Temps plein

    RA/QA Officer:QA/RA - Belgium:Department: QA/RAType: PermanentBased: HybridSalary: CompetitiveClosing Date: 17/03/2024Start Date:IDS est l'un des principaux fournisseurs en solutions de diagnostic in vitro sur le marché des laboratoires cliniques. Nous développons, fabriquons et commercialisons des immunoessais innovants et des technologies d'immunoanalyse...

  • Clinical Affairs Manager

    il y a 2 semaines


    Watermael-Boitsfort, Région de Bruxelles, Belgique Covartim Temps plein

    Functieomschrijving:The Clinical Affairs Manager shall provide support for the development of innovative medical devices, as part of the development team within COVARTIM.(S)he will manage Clinical Affairs activities such as, but not limited to: Preparation of CEP and CER Management of clinical investigation Set up and follow up of PMS, PMCF, PSUR Review and...


  • Bruxelles, Région de Bruxelles, Belgique MedTech Europe Temps plein

    As a member of the Member Relations & Services Department, the Senior Manager IVD shares responsibility for the strategic development of the association and contributes to the initiation and implementation of a broad range of activities.This position's primarily focus is to be a credible advocate for the IVD industry, and liaison officer with all IVD members...

  • Intern - Sustainability Team

    il y a 2 semaines


    Bruxelles, Région de Bruxelles, Belgique MedTech Europe Temps plein

    Intern - Sustainability teamMedTech Europe is looking for an intern to support its Sustainability team. Over the duration of the internship, the intern will be able to familiarise himself/herself with the EU sustainability agenda and with the functioning of the main European trade association representing the views of the medical technology industry in...

  • Intern Communications

    il y a 2 semaines


    Bruxelles, Région de Bruxelles, Belgique MedTech Europe Temps plein

    As part of MedTech Europe's External Affairs team, the Intern Communications is responsible in supporting different projects aligned with MedTech Europe's communications, social media and media strategy.Specific ResponsibilitiesMedTech Europe internal & external newsletters:Compile and edit content for newsletters Support the setup and the dissemination of...


  • Bruxelles, Région de Bruxelles, Belgique MedTech Europe Temps plein

    Key areas of responsibility- The primary area of responsibility will be in following and influencing the implementation of the Health Technology Assessment (HTA) Regulation in the field of medical devices. In principle, HTA serves to provide a framework for the evaluation of medical technologies with a view to adopting them in various healthcare settings.-...

  • Quality Assurance

    il y a 2 semaines


    Bruxelles, Région de Bruxelles, Belgique Covartim Temps plein

    **Een superheld die zich inzet voor de conformiteit van medische hulpmiddelen**Betekenen ISO 13485, 21 CFR, 510(k), MDR 2017/745, IVDR 2017/746 voor jou meer dan een reeks cijfers en letters?Schrikt het parallel werken aan verschillende projecten je niet af? Maar ben je juist op zoek naar een afwisselende baan?Als je weet dat jouw job een impact kan hebben...

  • Intern Government Affairs

    il y a 2 semaines


    Bruxelles, Région de Bruxelles, Belgique MedTech Europe Temps plein

    The traineeship is aimed at recent graduates wishing to acquire professional experience in EU public affairs, and more specifically in the healthcare sector. The main responsibility of the intern will be to support the day-to-day activities of MedTech Europe's Government Affairs & Public Policy team.As a European trade association based in Brussels...

  • Intern Communications

    il y a 2 semaines


    Bruxelles, Région de Bruxelles, Belgique MedTech Europe Temps plein

    As part of MedTech Europe's External Affairs team, the Intern Communications is responsible for supporting different projects aligned with MedTech Europe's communications, digital platforms and media strategy. The intern reports to the Officer Communications.Specific Responsibilities:Media monitoring: Monitor daily media alerts Daily dissemination of news to...

  • Quality Assurance

    il y a 2 semaines


    Bruxelles, Région de Bruxelles, Belgique Covartim Temps plein

    **Superheld die zich inzet voor de conformiteit van medische hulpmiddelen**Betekenen ISO 13485, 21 CFR, 510(k), MDR 2017/745, IVDR 2017/746 voor jou meer dan een reeks cijfers en letters?Schrikt het parallel werken aan verschillende projecten je niet af? Maar ben je juist op zoek naar een afwisselende baan?Als je weet dat jouw job een impact kan hebben op de...

  • Industrial Policies Manager

    il y a 2 semaines


    Bruxelles, Région de Bruxelles, Belgique MedTech Europe Temps plein

    Company detailsWhy work for MedTech Europe?Are you passionate about healthcare and medical technologies?Do you want to play a role in shaping policies to promote innovation for the growing healthcare needs?In that case MedTech Europe the European Trade Association representing the medical technologies' industries, has the ideal job for you.You will be...


  • Bruxelles, Région de Bruxelles, Belgique MedTech Europe Temps plein

    Key responsibilities and activities The primary role will be to support the colleagues responsible for the implementation of the new digital health legislation. More specifically, you will support the implementation of key legislative files in the field of health data governance, artificial intelligence and cybersecurity.- Members Coordination MedTech Europe...

  • Senior Manager Communications

    il y a 2 semaines


    Bruxelles, Région de Bruxelles, Belgique MedTech Europe Temps plein

    The Senior Manager will establish and lead the organisation's communication objectives in line with the vision and goals of the association and the medical technology sector. They will set out the communications strategy, ensuring that all communications initiatives and channels, including media, campaigns, digital channels, blogs, event communications,...

  • Industrial Policies Manager

    il y a 2 semaines


    Bruxelles, Région de Bruxelles, Belgique MedTech Europe Temps plein

    Why work for MedTech Europe?:Are you passionate about healthcare and medical technologies?Do you want to play a role in shaping policies to promote innovation for the growing healthcare needs?In that case, MedTech Europe, the European Trade Association representing the medical technologies' industries, has the ideal job for you.You will be responsible (under...

  • Industrial Policies Manager

    il y a 2 semaines


    Bruxelles, Région de Bruxelles, Belgique MedTech Europe Temps plein

    Why work for MedTech Europe?:Are you passionate about healthcare and medical technologies?Do you want to play a role in shaping policies to promote innovation for the growing healthcare needs?In that case, MedTech Europe, the European Trade Association representing the medical technologies' industries, has the ideal job for you.You will be responsible (under...

  • Conference Vetting System's

    il y a 2 semaines


    Bruxelles, Région de Bruxelles, Belgique MedTech Europe Temps plein

    Reports to:MedTech Europe Compliance PanelBackground:In the field of healthcare compliance, MedTech Europe's and EFPIA's Member companies have recognised the need for and value of guarding and promoting their reputation for integrity and responsibility as stakeholders become less tolerant of lapses. A focus of attention are the interactions with Healthcare...