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Manufacturing and Industrialization Manager - Chemicals - Belgique

Known as one of the 5 « Supermajors », our client is a top player in the global oil and gas industry, as well as a leader in industrial chemistry.

In an increasingly competitive environment due to imports of commodity products, and in order to protect its intellectual property and secure its catalytic developments, our client has decided to develop, produce and sell metallocene catalysts.

In order to ensure the development of our client’s polymer plant located in the south of Brussels, we are actively looking for a (m/f):

Manufacturing and Industrialization Manager

New Generation Catalysts
Responsibilities:

As a Manufacturing and Industrialization Manager of New Generation Catalysts, you coordinate the start-up of the production unit of these catalysts. Reporting to the Executive Committee, you are the technical referent and you supervise the production team.

The following responsibilities are entrusted to you:

  • Coordinate and optimize catalyst production in terms of resources, process and results, according to the required specifications.
  • Optimize the application of new process and catalytic versions, in close collaboration with the research and the process department.
  • Maximize the production unit financial profitability by ensuring cost reduction (debottlenecking, solvent recovery, etc.).
  • Implement and ensure compliance with quality (QC/QA) and safety standards.
  • Implement a procedure and ensure performance monitoring.
  • Collaborate closely with the supply chain.
  • Be the technical responsible for the catalysts purchased from tollers.
  • Ensure the customer follow-up worldwide in terms of performance.
  • Supervise, motivate and develop the production team.
Profile:
  • You have a Master’s degree/PhD in Chemistry.
  • You have at least 10 years of experience in scale-up and industrial manufacturing of polyolefin catalysts. As such, you have acquired a solid knowledge in polymerization, and ideally in downstream applications.
  • You have experience in the management of a catalyst operating team (pilot/industrial unit).
  • You are comfortable with project management and you enjoy teamwork.
  • You are autonomous, rigorous, with a strong ability in decision-making and leadership.
  • You have a very good command of English.
  • You are willing to travel occasionally on all continents.
  • You are ready to relocate internationally.
Offer :
  • A strategic and diversified position linked to innovative projects.
  • Development opportunities and a structured evolution plan.
  • Integrate an innovative and globally renowned industrial company.
  • Professional and stimulating challenges, as well as rewarding human contacts.
  • A competitive salary package, in line with your experience.

Research Assistant – Flow Cytometry and Serology - Bio-Pharma/Biotech - Gosselies

Caprion Biosciences is a contract research organisation with facilities in Montreal (Canada) and Gosselies (Belgium). Caprion Biosciences offers analytical services to biopharmaceutical companies ranging from mass spectrometry-based analytical services to the characterization of the human immune response in clinical samples.

Caprion Biosciences operates globally, with partners in North America, Europe and Asia, including large pharmaceutical companies and biotech companies.

In the context of its growing immune monitoring service offering in Gosselies (Belgium), we are looking for a (m/f):

Research Assistant – Flow Cytometry and Serology

Responsibilities :

Reporting to the Laboratory Manager and working closely with Principal Scientists, the Research Assistant will work within a team focusing on the characterization of the cellular (ELISPOT and various flow cytometry assays such as phenotyping of PBMC, detection of intra-cellular cytokines, etc) and of the humoral (ELISA, Luminex, viral neutralization tests, etc) immune response.

Tasks include :

  • Perform immunoassays according to current standard operating procedures;
  • Participate to the writing and/or to the review of method SOP and worksheets;
  • Manage reagents inventories and orders;
  • Participate to the technical management of the laboratory;
  • Perform work according to internal quality standards, apply relevant Quality System procedures and participate to the continuous improvement of Quality documents;
  • Attend relevant internal training activities;
  • Depending on the experience level of the candidate, additional tasks may include:
    • Act as a leader in the laboratory for specific studies;
    • Work with the Principal Scientist to prepare experimental plans needed for the conduct of immune monitoring assays;
    • Participate in the development and qualification/validation of complex methods;
    • Participate in experiment planning and problem solving.
Profile :

The applicant must hold a bachelor degree or a master’s degree (or the equivalent) in a life science discipline such as biology, medical biology or biochemistry/biotechnology and demonstrate a relevant laboratory experience. Theoretical and practical knowledge of techniques related to cellular and humoral immunology is required. Experience in cell culture and handling infectious materials in BL2+ environment is an asset.

The applicant must :

  • Demonstrate excellent organisational skills.
  • Demonstrate schedule adaptability and flexibility.
  • Be willing to actively participate to the generation, the implementation and the continuous improvement of laboratory processes.
  • Be willing to work in a Quality environment (ISO17025, GCLP, GMP) and apply good documentation procedures (GDP).
  • Be functional in French (spoken and written) and have a functional knowledge of written English. Knowledge spoken English is an asset.
Offer :
  • Full time permanent contract, with possibility of rapid start.
  • Diversified tasks and responsibilities and interesting projects.
  • A professional, dynamic and stimulating work environment.
  • Training and development opportunities.
  • A competitive salary package including benefits, adapted to your experience and the context.

Senior Operations Manager – Radio-Pharma - Radio–Pharma - Fleurus

Situées à Fleurus (Belgique), l’IRE et sa filiale IRE ELiT sont des entreprises industrielles renommées et innovantes.

Avec plus de 185 collaborateurs, l’IRE est un des principaux producteurs mondiaux de radio-isotopes utilisés en médecine nucléaire à des fins de diagnostic et de thérapie. IRE ELiT est active dans la protection de l’environnement et dans la production radio-pharmaceutique.

Ces entreprises contribuent à la santé de millions de patients dans le monde chaque année. Sur les 5 dernières années, l’entreprise a renforcé son développement et jouit d’une croissance continue. Veuillez consulter www.ire.eu.

Pour assurer le bon développement de l’IRE ELiT, nous sommes activement à la recherche d’un (m/f) :

Senior Operations Manager – Radio-Pharma

Responsabilités :

Rapportant à la direction générale, vous avez la responsabilité de la partie industrielle de l’IRE-ELiT. Vous implémentez la stratégie de l’entreprise : vous coordonnez les opérations de production, d’entreposage, d’approvisionnement et de distribution des produits, tout en veillant au respect des normes de qualité. Le plan d’affaire de la société prévoyant une importante croissance dans les années à venir, vous aurez la responsabilité d’assurer la capacité industrielle suffisante de telle sorte que l’approvisionnement du marché soit garanti en quantité, délais et qualité.

Les responsabilités suivantes vous sont confiées :

  • Coordonner et optimiser le fonctionnement de la production radio-pharmaceutique.
  • Diriger, motiver et développer les collaborateurs de l’équipe.
  • Mettre en œuvre la stratégie de l’entreprise au sein des opérations.
  • Veiller au respect des normes de qualité dans un environnement GMP de production de médicaments stériles injectables, et au respect des normes environnementales et de sécurité.
  • Mettre en œuvre une politique d’amélioration continue et d’optimisation des investissements.
  • Planifier et contrôler l’évolution du budget, accompagné par le département financier.
  • Interagir, en tant que principal point de contact, avec les institutions externes.
  • Rapporter de manière structurée, rigoureuse et adaptée les résultats des activités.
Profil :
  • Vous êtes titulaire d’un Master en Pharmacie, Chimie, Biotechnologie, Ingénieur ou équivalent.
  • Vous disposez de minimum 10 années d’expérience dans une fonction comparable au sein d’un environnement GMP.
  • Vous avez, par votre expérience ou vos formations antérieures, un intérêt marqué et des connaissances de bases généralistes en business management (finance, marketing, stratégie, gestion des opérations…).
  • Vous démontrez de l’aisance dans la gestion d’équipe et de projets.
  • Vous communiquez efficacement, avec assertivité, et possédez une certaine aisance relationnelle.
  • Vous possédez une bonne connaissance du français et de l’anglais.
  • Vous êtes polyvalent, autonome, organisé et rigoureux.
  • La connaissance des outils du LEAN Manufacturing est un sérieux atout.
Offre :
  • Une fonction stimulante et diversifiée incluant des responsabilités et des projets intéressants.
  • Des défis professionnels, financiers et humains stimulants et enrichissants.
  • Des contacts variés avec des acteurs majeurs de l’industrie.
  • L’opportunité de renforcer une structure industrielle renommée, innovante et en forte croissance.
  • Un salaire attractif reprenant des avantages extra-légaux, en phase avec votre expérience.

Ingénieur Commercial Grands Comptes - Energie - Paris

Dunkerque LNG est en charge de l’exploitation et de la commercialisation du terminal méthanier de Dunkerque, deuxième plus grand terminal méthanier d’Europe continentale.

Fort d’un chiffre d’affaire annuel de 190€ millions, Dunkerque LNG est un atout majeur dans le développement de la stratégie d’approvisionnement en gaz du groupe EDF en raison de son raccordement unique à deux marchés de consommation : la France et la Belgique.

La société est composée d’une vingtaine de collaborateurs répartis sur les sites de Dunkerque et de Paris La Défense.

Afin de renforcer l’équipe commerciale de Dunkerque LNG à Paris, nous sommes activement à la recherche d’un (h/f) :

Ingénieur Commercial Grands Comptes

Responsabilités :

En tant qu’Ingénieur Commercial Grands Comptes, vous participez activement au développement du terminal tant d’un point de vue commercial qu’opérationnel. Rapportant au Directeur Commercial, vous êtes responsable de la relation commerciale avec les clients et les différents partenaires de Dunkerque LNG.

Vos principales responsabilités sont les suivantes :

  • Entretenir et développer la relation commerciale avec les clients de Dunkerque LNG, EDF et Total.
  • Veiller au respect des contrats de réservation de capacité et de leur mise en œuvre opérationnelle.
  • Supporter la Direction Commerciale dans le pilotage de la relation contractuelle et/ou opérationnelle des prestataires : suivi du contrat de service, lancement et réception de nouveaux développements, etc.
  • Prospecter de nouveaux clients, notamment en participant à différents forums et salons industriels.
  • Planifier et gérer l’activité du terminal : bateaux, émission, stock, etc.
  • Rapporter de manière régulière la performance commerciale et opérationnelle du terminal.
  • Participer aux astreintes de soutien à raison d’une semaine sur quatre.
Profil :
  • Vous êtes titulaire d’un Bac+5 de type école de commerce, d’ingénieur ou universitaire.
  • Vous disposez de 10 ans d’expérience dans une fonction commerciale dans le secteur gazier.
  • Vous êtes orienté(e) clientèle, résultats et solutions, et doté(e) d’un très bon relationnel.
  • Vous êtes flexible, autonome, organisé(e), analytique et rigoureux(se).
  • Vous communiquez aisément en Français et en Anglais.
  • Vous êtes basé(e) à Paris La Défense et disposé(e) à vous déplacer de manière régulière à Dunkerque et ponctuellement à travers le monde.
Offre :
  • Une fonction stimulante au sein d’un environnement diversifié.
  • L’opportunité de rejoindre un acteur majeur dans l’industrie du gaz en Europe.
  • Des challenges et des contacts variés au sein et en dehors de l’organisation.
  • Des opportunités de développement et de formations.
  • Un salaire attractif reprenant des avantages extra-légaux avantageux.

Business Development Manager – CRO - Bio-Pharma/Biotech - Gosselies

Caprion Biosciences is a contract research organisation with facilities in Montreal (Canada) and Gosselies (Belgium). Caprion Biosciences offers analytical services to biopharmaceutical companies ranging from mass spectrometry-based analytical services to the characterization of the human immune response in clinical samples.

Caprion Biosciences operates globally, with partners in North America, Europe and Asia, including large pharmaceutical companies and biotech companies.

In the context of its growing service offering in Europe, we are looking for a (m/f):

Business Development Manager – CRO

Responsibilities:

Reporting to the Business Development Director, you work closely with the entire business development team to drive new business in Europe, including lead generation, pipeline management, deal negotiation and key account management. You identify and develop strategic business opportunities within pharmaceutical and biotech organizations. As a real hunter, your main responsibilities include:

  • Expand the business in new and existing markets.
  • Build and leverage relationships within the Translational Medicine and Clinical departments of pharma/biotech organizations.
  • Expanding the Company’s reputation with key decision makers to enhance the credibility of its services and brand.
  • Develop and propose relevant technical/scientific solutions to meet customers’ needs.
  • Develop monthly, annual, and multi-year sales forecasts and measure results.
  • Cultivate relationships with strategic partners and expand sales opportunities with key accounts.
  • Report work evolution on a regular basis.
Profile:
  • Master or PhD in in a life science subject such as Physiology, Immunology, Protein Chemistry etc.
  • 5 years of demonstrated sales experience in the life-science industry: CRO, CMO, Biotech/Pharma.
  • Excellent communication, relationship, networking and deal making abilities.
  • Strong scientific understanding of immune monitoring or mass spectrometry based solutions.
  • Ambitious, driven, reliable, autonomous with a clear sense of ethics.
  • Solutions-oriented, results- and clients-centered.
  • Fluency in English (written and spoken). The command of German is an asset.
  • You demonstrate excellent entrepreneurial and organisational skills.
  • You are prone to travel around 50% of your work time.
  • You will be home based in Germany, Switzerland or Scandinavia although other EU location may be considered.

Offer:

  • A challenging business development position with a fast-growing company.
  • A full time permanent position with development and evolution opportunities.
  • A professional, dynamic and stimulating international work environment.
  • The opportunity to have direct impact on the company’s results and growth.
  • A competitive salary package including benefits, adapted to your experience and the context.

Program Management Officer - Biotechnology - Gosselies

Located in Gosselies (Belgium), MaSTherCell is a service company (CDMO) in biotechnology. MaSTherCell is specialized in production outsourcing, process development and quality management (QA/QC/QP) for cell therapy.

With around 110 employees, MaSTherCell supports its customers (big pharma, biotech, etc.) in the development and production of innovative medicines. MaSTherCell actively contributes to improving the quality of life and health of many patients. For more information, please visit http://www.masthercell.com.

To support MaSTherCell in its strong growth, we are actively looking for a (m/f):

Program Management Officer

Responsibilities:

Reporting to the Executive committee, you assist them in selecting and planning strategic internal projects/programs (including new sites integration), and in reporting on their progress.

Your main responsibilities are:

  • You implement project management tools, project control processes, procedures and policies.
  • You monitor and control the internal program/project throughout their entire lifecycle.
  • You select program/project and you argue program/project closedown if necessary.
  • You assess the relative priority of internal projects and programs.
  • You set up performance reporting and program/project governance for customer and internal projects.
  • You lead the project financial tracking with the business controller.
  • You provide support to project teams and task planning.
  • You report your work on a regular basis.
Profile:
  • Master’s degree in Engineering, Life Sciences or any related field.
  • Minimum 3 years experience in project management in the pharmaceutical industry and/or in a consulting services company.
  • A project management professional certification is an asset.
  • Strong communication skills together with hands-on and pragmatic mind-set.
  • Very good organizational, analytical and problem-solving skills.
  • Highly collaborative, self-motivated and team-oriented individual in a company setting.
  • Good oral and written communication skills in English. Any other language is a plus.
  • Computer skills:  Microsoft office, Digital document management system and Project management IT tools.
Offer:
  • A challenging and diversified position within a high-potential innovative biotech company.
  • To work in a human size, dynamic, respectful and professional environment.
  • A variety of interesting contacts with international exposure.
  • An attractive compensation package in line with the position responsibilities and your experience.

Technical Advisor - Automotive - Brussels

Based in Brussels (Belgium), FIGIEFA is the European federation and political representative of the independent wholesalers and retailers of automotive replacement parts. Together with its 19 national European Member State members, it represents the interests of more than 30.000 companies trading with vehicle parts, components and accessories throughout Europe.

The aim of FIGIEFA is to safeguard a legislative environment in the EU that provides access to technical information, to the ‘connected vehicle’ and its in-vehicle data as well as to replacement parts/equipment as the basis for free and fair competition in the automotive aftermarket in a rapidly changing automotive technology environment.

In order to support the activities of its office in Brussels, we are currently looking for a (m/f):

Technical Advisor

Responsibilities:

As a Technical Advisor, you manage all technical and ‘connected vehicle’ IT-related dossiers and processes in connection with FIGIEFA’s activities in the area of the automotive aftermarket.

Your main responsibilities are:

  • Advise FIGIEFA in all technical and ‘connected vehicle’ IT-related matters.
  • Participate in meetings (in Brussels or EU) and take responsibility for the management of technical subjects and dossiers (e.g. telematics, EC type-approval legislation).
  • Support the FIGIEFA Secretariat in its information activities and meetings.
  • Advise and prepare answers on upcoming questions from the EU institutions and help in the preparation of position papers.
  • Liaise with FIGIEFA’s partner alliance AFCAR (Alliance for the Freedom of Car Repair in the EU).
  • Communicate with FIGIEFA legal/political experts and work out common strategies, statements, papers and positions.
  • Report results and work evolution on a regular basis.
Profile:
  • You are an experienced automotive technical expert or are experienced in vehicle-related IT technologies around the ‘connected vehicle’ (e.g. telematics and cybersecurity).
  • You are, preferably, specialised in vehicle communication, vehicle design/functionality, diagnostics or contemporary and developing vehicle technologies.
  • You have excellent oral and written communication skills in English and strong interpersonal skills.
  • You are flexible, proactive, and able to work on your own as well as in close cooperation with the FIGIEFA Secretariat.
  • You are able to assess the business consequences of new legislation, automotive technologies and vehicle related services.
  • You are ready to travel frequently to other European countries.
Offer:
  • A challenging position within a multi-national and political environment that tackles a wide range of technical issues.
  • The opportunity to support and promote free and fair competition in the automotive aftermarket and to safeguard a legislative environment at EU level.
  • Various contacts with European and international institutions while representing the interests of FIGIEFA members.
  • An attractive salary package in line with the position responsibilities and your experience.

Lead Scientist - Bio-Pharma/Biotech - Gosselies

ImmunXperts is a high-potential start-up based in Gosselies, Belgium. This fast-growing company offers a wide range of Immunology services with a constant will to develop customized solutions for its clients.

The offerings include in vitro assays to assess the immunogenic potential of test molecules using T cell activation and proliferation assays as a surrogate marker for the induction of Anti-Drug-Antibodies. On the immuno-oncology side, ImmunXperts develops in vitro assays to assess the functionality of candidates. ImmunXperts continuously develops new cellular immune-assays to assist biotech and pharma companies directly in their product development. Other such collaborative services include protocol optimization and in-house training. More info can be found on www.immunxperts.com.

ImmunXperts’ team works in an open-minded, science-driven and fast-paced environment. In order to support their growth, ImmunXperts is actively looking for a (m/f) :

Lead Scientist

Mission:

We are looking for a Lead Scientist to plan, direct and coordinate ImmunXperts’ R&D lab operations.

You are responsible for improving overall performance, productivity and efficiency through the implementation of effective methods and strategies. You show thorough scientific background combined with excellent organizational and interpersonal skills. You coordinate a team of high-level scientists who lead between 50 and 100 different projects per year.

Main responsibilities:

On a daily basis, you understand and dive into ImmunXperts’ team activities in order to:

  • Coordinate cross-project activities together with project leaders:
    • Monitor project progress and take corrective actions if needed, ensuring that all projects are delivered on time and using foreseen resources.
    • Lead (Senior) Scientists, providing them with guidance where and when appropriate: cellular assays development and optimization, data analysis, client interaction, technical & scientific writing.
    • Organize and manage priorities in order to meet project and client deadlines.
    • Strong interest to participate in all lab activities when appropriate (challenging project, temporary high workload, transfer of knowledge,…).
  • Ensure overall lab quality through:
    • Use of standard methods and procedures by all, for all experiments.
    • Optimize resources flow and allocation inside the lab to maximize operational performance.
    • Coordinate continuous improvement initiatives to maintain an overall high level of quality (procedures, techniques, equipment, security…)
  • Daily manage lab technicians in the best interest of all projects and transversal activities, leading by example.
  • Possibility to attend international conferences and give technical and scientific presentations. Occasional travel to prospects and clients worldwide.
Profile requirements:
  • Master or Ph.D. in Immunology, Biology, Pharmaceutical Science, or equivalent by experience.
  • 5 to 10 years experience with cellular assays, in an industrial/biotech environment.
  • Strong experience in elisa and flow cytometry. Luminex and elispot expertise are a plus.
  • Ability to see the global picture with a rigorous mindset and attention for details.
  • Leadership and organizational skills. Clients, solutions and results oriented.
  • Outstanding communication and inter-personal skills.
  • Excellent knowledge of MS Office; working knowledge of program/project management software (Basecamp, MS Project etc.) is a strong advantage.
  • Excellent command of English (written and spoken). French and any other language is an asset.
  • Knowledge of project/program management techniques and methods is an advantage.

Spécialiste Médias Sociaux - Vente - Humbeek

Krëfel est une chaîne belge de magasins spécialisés dans la vente de l’électroménager, de matériels informatiques et audiovisuels (télévision et audio) ainsi que de cuisines.

Le réseau Krëfel représente aujourd’hui 75 points de vente répartis sur l’ensemble du territoire belge, sans compter ceux implantés au Luxembourg. La chaîne emploie actuellement plus de  1000 salariés. En outre, Krëfel tire avantage d’un site e-commerce de haute performance.

Spécialiste Médias Sociaux

Responsabilités :

En tant que Spécialiste Médias Sociaux, vous gérez toutes les activités liées aux réseaux sociaux dans l’écosystème digital. Vous êtes responsable du community management et de la publication de contenu sur diverses plateformes.

Vos responsabilités sont les suivantes :
  • Vous définissez la stratégie de communication concernant les médias sociaux.
  • Vous créez, gérez et renforcez la présence en ligne et la communication digitale.
  • Vous rédigez des articles pour les blogs, les pages produits et les newsletters.
  • Vous publiez du contenu sur les réseaux sociaux (Twitter, Facebook et LinkedIn).
  • Vous optimisez l’image de marque dans tous les formats digitaux (visuels et textuels).
  • Vous garantissez un bon suivi des campagnes de communication en cours.
  • Vous mettez en place des KPI et êtes responsable du budget alloué aux médias sociaux.
  • Vous restez à jour sur les tendances et ajustez la stratégie de contenu si nécessaire.
  • Vous rapportez de manière détaillée les résultats des actions aux stakeholders internes.
Profil :
  • Baccalauréat ou Master en communication, marketing, journalisme, relations publiques.
  • Une première expérience en gestion de plateformes de médias sociaux ou en création d’une community pour une marque.
  • Expérience en branding, en communication digitale et en réalisation audio-visuelle.
  • Très bonne aisance relationnelle, tant à l’oral qu’à l’écrit.
  • Excellentes capacités rédactionnelles.
  • Créatif(ve), analytique, proactif(ve) et sens des initiatives.
  • Excellente maîtrise du français. Tout autre langue en plus est un atout.
Offre :
  • Une fonction diversifiée au sein d’une entreprise renommée et en pleine croissance.
  • Des possibilités de formations, de développement et d’évolution de carrière.
  • Beaucoup d’espace pour l’initiative, la créativité et le développement personnel.
  • Un cadre de travail agréable et chaleureux.
  • Un contrat à temps plein et à durée indéterminée, assorti d’un package salarial adapté à votre profil et à votre niveau d’expérience.

Senior Design Assurance Manager - Medical Device - Awans

Miracor Medical is a class IIb/III medical device company specialized in improving clinical outcome of patients with impaired cardiac function, active in interventional cardiology. The company has developed a high potential proprietary technology that consists of hardware, software and catheter(s).

The technology is in advanced clinical stages, with various potential therapeutic applications (among others acute infarct and heart failure). More than 190 patients have been treated with the recent version of the technology. The company aims at getting CE Mark and approval from FDA to run a pivotal study in the next 2 years.

Miracor Medical’s offices are based in Awans, Belgium. The company is now looking for talented and enthusiastic talents to expand its international team. For additional information about the company and its technology, please visit www.miracormedical.com.

Miracor Medical offers a culturally diverse English speaking working environment in the heart of Europe, Belgium, a few hours away from Europe’s capital cities.

To support the development of the company, we are looking for a (m/f):

Senior Design Assurance Manager

Responsibilities:
  • You provide design assurance support and oversight for product development activities throughout product lifecycle.
  • You create, review and/or execute IQ, OQ, PQ and test method development.
  • You ensure product development follows company procedures and design control requirements.
  • You review and approve design verification and design validation test protocols and reports.
  • You support protocol sample size calculations and data analysis with use of acceptable use of statistical methods/techniques.
  • You drive robust design reviews within R&D teams.
  • You ensure compilation and maintenance of product Design History Files.
  • You document traceability of requirements through design output and to design verification and/or design validation.
  • You lead the risk management process for pre-market and post-market assessments of assigned products.
Profile:
  • Bachelor or Master’s degree in Engineering, Life Sciences or another related field.
  • 10+ years’ experience working in a Quality or Engineering capacity with Class III medical devices. Experience with catheters and active devices preferable.
  • Experience with all phases of the product development process including clinical investigation.
  • Experience in creating and maintaining Risk Management Files.
  • Deep understanding of MDD (MDR), FDA 21 CFR 820, ISO13485 and ISO14971 standards.
  • In-depth knowledge of the concepts of: design control, engineering change control, statistical techniques, verification and validation methods/protocols, design history files (DHF) and device history and master records (DHR/DMR).
  • Extensive understanding of statistical analysis, measurement and calibration systems, quality testing, sampling and inspection, process control, SOPs, etc.; Six Sigma certificate.
  • Excellent organisational and communication (oral and written) skills.
  • Ability to work on teams as well as individually.
  • Fluent in English (oral and written).
Offer:
  • A challenging and diversified position within a high-potential innovative medical device company.
  • To work in a human size, dynamic, respectful and professional environment.
  • International exposure, with learning and development opportunities.
  • An attractive compensation package in line with the position responsibilities and your experience.