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Our client is a supplier of high-quality medical products. They specialise in products for wound, continence, diabetes and acute (first aid) care. They offer a wide range of brands, including their own. These products have been developed on the basis of the latest insights and developments in healthcare. They are a dynamic and fast-growing company with 50+ employees. Our client has an open, informal culture with short lines of communication. Hard work go hand in hand with solidarity and a pleasa...

As a Quality Engineer you will be part of the Quality Department and report to the Quality Manager. You work closely together with the Product Managers. You will be responsible for the preparation and maintenance of the technical files in support of CE marking of existing and new medical devices. Besides this you will assess the production methods and quality processes at suppliers and distributors. You will make root cause analyses through quality data analysis and failure analysis process and ...

o bachelor or master with minimum 3 years" experience o experience with the medical device sector in wound, continence, diabetes and acute (first aid) care is a plus o trained and knowledge of process and product audits o experience with ISO13485 and medical devices regulation o good analytical and logic deduction skills, problem solver o good communication and negotiation skills o strong oral and written communication in Dutch and English o preferably located in Venray (NL) area ...

A temporary position as a Software Engineer for the Quality system until the end of the year at a global healthcare company...

Our client is international active in the healthcare industry. They produce and sell their products on the international market. They are always looking for new innovative medical device products by investing in research and development. With this investments they hope to stay on top of the market. They design the product through the eyes of the end user combined with an appealing design. The organisation is always looking for improvement of their processes, therefore they like to get in touch w...

The Software Quality Assurance Engineer role is a vital organizational component ensuring regulated automated tools used in the Quality System are appropriately validated and controlled through their life cycle from development, deployment, change control and retirement. This includes ensuring project teams adhere to processes and control mechanisms for software, hardware, data and relevant security to meet regulatory requirements. In this role it is your responsibility to enforce policies and...

o at least 7 years of experience in validation of computer systems and systems security and control including supervision of a technical professional staff o experience working in disciplined regulated industry in the application of automated technology particularly 21 CFR, ISO 13485, GAMP 5 o multiple years of experience with computerized systems implementations, comprised of multiple application types, in a regulated environment o demonstrated ability to interact and communicate (both or...

Een tijdelijke uitdagende technician functie bij een succesvolle organisatie voor de duur van ongeveer zeven maanden. Uitzicht op een vaste aanstelling. ...

Onze relatie is een wereldwijd gerenommeerde organisatie die zich richt op de ontwikkeling, productie en marketing van vaccins en antilichamen tegen infectieziekten. Binnen de organisatie werken getalenteerde, ondernemende mensen in een dynamische cultuur waarin innovatie en een 'can do' mentaliteit centraal staan. Momenteel is de organisatie op zoek naar een ervaren Quality Control Technician om het team te versterken en de kwaliteit van de producten te waarborgen....

Als Quality Control Technician maak je deel uit van het ELISA QC team. Je voert QC taken uit op geproduceerde componenten (In-Process-Control) en geassembleerde kits (Final QC). Daarnaast voer je stabiliteitstesten uit om houdbaarheidsgegevens te generen en samples en kits veilig te stellen. Het voeren van materiële ingangscontroles behoren ook tot je takenpakket. Verder zorg je voor een continue beschikbaarheid van de werkvoorraad QC-panels. Je zorgt voor een accurate verslaglegging van QC data...

o afgeronde HBO-opleiding; o ervaring met het werken met kwaliteitssystemen (ISO/GMP) binnen een productie omgeving; o ervaring met het werken met ELISA; o accuraat, communicatief vaardig, verantwoordelijk, analytisch, teamplayer, proactief, gestructureerd en resultaatgericht; o uitstekende beheersing van de Nederlandse en Engelse taal in zowel woord als geschrift. ...

Diverse job responsibilities / informal, pragmatic and accessible culture / dynamic and growing international company (Amsterdam area, the Netherlands) ...

Our client is focused on improving peoples live with their healthcare products. They are dedicated to their commitments to patients, health care providers, other stakeholders and society. Their goal is to build an innovative company committed to advancing global health. A broad range of branded and generic pharmaceuticals, OTC products and medical devices is being manufactured and marketed all around the world. Their Dutch office is based in the Amsterdam region and the culture at their office ...

As a Head of QA EMEA you manage the Quality Management Systems for our client, Third Party Logistic distribution sites and Commercial Affiliates in EMEA. Besides this you will ensure distribution sites and commercial affiliates comply with (Inter)national legislation for the distribution of pharmaceutical and medical device products, cosmetics, food and food supplements. Your responsibilities include the definition, implementation and maintenance of efficient and effective quality systems for o...

o Pharmacist or Bachelor"s/ Master degree in Engineering or Related Science Field or equivalent o 6-10 years quality assurance experience, with a minimum of seven years management experience in medical device and/or pharmaceutical environment o experienced with FDA, EU Medical Device Directive, Pharmaceutical Quality System Regulations and GXP requirements (GDP, GMP) o analytical, financial and budgeting skills o team building skills o broad business perspective o ability to develop a visi...

An interesting postion to lead serveral projects within a European organization...

Our client is active worldwide in the development and production of commercial and clinical packaging materials. They have multiple offices and production locations around the world, employing around 1,800 people every day. For the location in Belgium they are looking for an experienced and enthusiastic Project Lead Technology & Serialization....

As a Project Lead Technology & Serialization you will be responsible for running multiple projects within the organsation. Your first priority is to lead the serialization project by implementing and continuously evaluate the European serialization approach. You lead, coache, guide, evaluate and assign the serialization team members. Notice that those team members are across European sites. You will be responsible for the creation, implementation and monitoring of the serialization vision and ar...

o Master level of education o more than 5 years of experience in Project management and Technology o specific experience with running a European serialization project o experience in leading mutidisciplinary project teams o affinity with IT systems o experience with MS Project and MS Office o GMP knowledge o fluent in both Dutch and English (spoken and written) o willing to travel within Europe ...

A challenging position in an organisation that focusses on healthy and sustainable food within Europe (Noord-Holland, The Netherlands) ...

The main goal of our client is to connect people to nature and by doing so helping them make better food choices for their own health and the health of our planet. To achieve this the company focusses on growing their brands in the core categories, upgrading their operations, building a green attractive and efficient company and on making selective acquisitions. The core categories in which the products are divided entail for example dairy alternatives, hot drinks, veggie meals and breakfast mea...

As a Nutrition & Regulatory Specialist you will ensure that the products and the communication are legally compliant. In addition, you will support renovation and innovation projects and you ensure that the products comply with the policies of the company. Responsibilities are monitoring the legal developments affecting the portfolio in The Netherlands and Belgium, as well as staying up to date on the developments in food at policy, ngo and on a scientific level in order to clearly advice Market...

o hbo+ in nutrition or food technology related or anything similar o 3+ years relevant experience, in a regulatory role and an interest in product development and preferably in FMCG o fluent in Dutch and English o some travel is required for this role o personality: pro-active, self-starter, taking initiative, result driven, outspoken enough to challenge internal stakeholders at all levels, precise, but also able to prioritise ...

Challenging and responsible position within a growing organization ...

Our client is a medical device company which is founded in 1989 in The Netherlands. The mission of the organisation is to produce and sell copper Intrauterine Contraceptive Devices (IUD"s). This organization assures that their products may be used safely and that the products functions according to their intended use. Their product obtained the CE Marking of Conformity in 1996 and renewed it ever since. Within this organization there are short communication lines and a lot of challenging project...

As a Quality Assurance and Regulatory Affairs Officer you will be part of a small team who is responsible for the set-up, maintenance and improvement of the quality and regulatory required systems. These systems ensure that the company is able to fulfil the best quality and regulatory requirements for its products. In consultation with top management and experts this team will establish, implement and maintain processes for the quality management system. Together with your colleagues you will be...

o at least a bachelor"s degree and academic experience o experience within the medical device industry o good analytical and system skills o excellent communication skills, both internally and externally o excellent language skills in English as well as in Dutch o driven, self-starting and collaborative ...

(geen informatie)

Our client is a supplier of high-quality medical products. They specialise in products for wound, continence, diabetes and acute (first aid) care. They offer a wide range of brands, including their own. These products have been developed on the basis of the latest insights and developments in healthcare. They are a dynamic and fast-growing company with 50+ employees. Our client has an open, informal culture with short lines of communication. Hard work go hand in hand with solidarity and a pleasa...

As a Quality Manager you will work in close cooperation with all departments in the company and with our client suppliers and distributors. In this role you will be responsible to guarantee the quality policy of the company. You will ensure that this policy is understood, implemented and maintained at all levels of the organisation while complying with the applicable regulatory requirements. Besides this you will assess the regulatory requirements for new products, define the regulatory strategy...

o bachelor"s or master"s degree in life science or engineering area o preferably minimum of 5 years" experience in EU regulations/ standards related to wound, continence, diabetes and acute (first aid) care o experience leading and facilitating audits o results and customer oriented, rigorous, autonomous and flexible o knowledge and experience of medical devices, MDR and ISO 13485 o strong oral and written communication in Dutch and English o great organisational skills and a "gettin...

Uitdagende functie - dynamische organisatie - ruimte voor persoonlijke ontwikkeling...

Onze opdrachtgever is een wereldspeler binnen de farmaceutische zorgketen, die actief is in meer dan 25 landen. In Nederland zijn meer dan 1.500 medewerkers actief. Door hun unieke positie zijn zij in staat de verschillende behoeftes van stakeholders binnen de keten te integreren en zo tot innovatieve oplossingen te komen. De gezondheid en het welbevinden van de klant vormen daarbij de verbindende factor. Authenticiteit, initiatief en groei zijn de sleutelfactoren voor succes. Onderdeel van het ...

Het doel van deze functie is het ontwikkelen, in stand houden, verbeteren en beheren van een beheersbaar geïntegreerd en volgens geldende normen gecertificeerd kwaliteit-systeem. Alle kwaliteitssystemen (ISO 9001 en GDP onder andere) van de organisatie worden momenteel en in de nabije toekomst samengevoegd in een alles omvattend systeem. In deze positie neemt de QA Specialist het integreren van het Kwaliteit-systeem in dit alles omvattende systeem voor zijn/haar rekening. Hiermee levert de QA Sp...

o hbo+ / wo-opleidingsniveau in een farmaceutische/ logistieke richting o minimaal 3 jaar ervaring in een soortgelijke logistieke kwaliteitsfunctie; o bij voorkeur geregistreerd staan als Responsible Person bij een logistieke onderneming, indien dat niet het geval is actief meewerken om op korte termijn als zodanig geregistreerd te worden; o kennis van, affiniteit met en begrip van de farmaceutische (logistieke) branche; o kennis van, affiniteit met en begrip van (inter)nationale wet- en reg...

A-merken in OTC-branche / breed productenpakket / dynamisch / veel verantwoordelijkheid (Zuid-Holland, Nederland) ...

De organisatie is één van de grootste organisaties in de zelfzorg en personal care industrie wereldwijd. Het bedrijf beschikt over een breed en snel groeiend portfolio zelfzorgproducten, bestaande uit geneesmiddelen, medische hulpmiddelen, biociden, voedingssupplementen en cosmetica. Er werken op dit moment circa 60 enthousiaste professionals aan het succesvol op de markt brengen van de producten en het uitbreiden van het portfolio. De organisatie werkt sterk datagedreven en is continu op zoek n...

Als QA Manager & Responsible Person ben je hoofdzakelijk verantwoordelijk voor het voldoen aan de wettelijke QA-eisen in het binnen- en buitenland. Dit houdt in het houden van toezicht op de juiste wijze van opslag, transport en distributie. Aanvullend geef je medewerkers training en advies ten aanzien van de wet- en regelgeving en QA-systemen. Je ziet erop toe dat de QA-systemen juist zijn opgezet, onderhoudt deze, voert zelfinspecties en externe inspecties uit bij toeleveranciers en je zorgt d...

o universitaire opleiding in een relevante richting zoals farmacie; farmaceutische, voedingskundige, chemische of biomedische wetenschappen of equivalent door ervaring; o kennis van en ervaring met GDP, GMP en bij voorkeur ook HACCP; o ervaring binnen een consumer healthcare organisatie met medische hulpmiddelen en/of cosmetica en kennis van Quality Assurance; o communicatief vaardig, zelfstandig, oplossingsgericht, flexibel, bouwer, daadkrachtig, een positieve instelling en ownership; o g...