Cleanroom Operator - Medical Devices

bA commercial product. A new cleanroom. A scaling team. /bbrLees de informatie in deze vacature zorgvuldig door om precies te begrijpen wat er van potentiële kandidaten wordt verwacht.brpXeltis is scaling up commercial manufacturing of its CE-marked vascular implants, and we are hiring experienced Cleanroom Operators to help us do it. You will produce our aXess™ vascular access graft in a newly built ISO Class 7 cleanroom at High Tech Campus Eindhoven, working to GMP and ISO 13485 standards in a growing production team. /pbrpOur flagship product has achieved CE marking and is moving from clinical stage into commercial-scale production. That means real volumes and real patients on haemodialysis who depend on what leaves our cleanroom. Rather than stepping into an established production line, you will help shape how our new facility operates from day one. /pbrpIf you have built medical devices or other high-precision products in a regulated environment, take pride in your work, and want to be early in a ramp-up rather than a cog in an established line, this is the moment to join. /pbrbWhat you will do /bbrpAs a Cleanroom Operator you will manufacture high-quality medical devices while ensuring full compliance with GMP and quality standards. Your responsibilities will include: /pbrullibr/liliManufacturing vascular implants in an ISO Class 7 cleanroom environment.br/liliPerforming precision manual assembly and operating production equipment according to approved procedures.br/liliExecuting in-process controls (IPC) and accurately documenting manufacturing activities.br/liliMaintaining complete, audit-ready batch records and production documentation.br/liliWorking closely with Quality Control and Quality Assurance on inspections and product release.br/liliIdentifying opportunities to improve process, quality, and efficiency as production volumes increase.br/liliSupporting the onboarding and training of new colleagues as you progress into a more senior role.br/li /ulbrbWhat we are looking for /bbrpbEssential /b /pbrullibr/liliMBO Level 4 qualification (or equivalent).br/liliMinimum 2 years of experience in a regulated manufacturing environment, such as:brullibr/liliMedical devicesbr/liliPharmaceuticalsbr/liliBiotechnologybr/liliGMP-regulated productionbr/liliISO 13485 environmentsbr/li /ulbr/liliHands-on experience with production documentation, batch records, and deviation management.br/liliExcellent manual dexterity and attention to detail that does not switch off.br/liliA strong sense of ownership: you flag and escalate quality concerns before they become deviations.br/liliGood communication skills and working proficiency in English (production language).br/li /ulbrpbStrongly preferred /b /pbrullibr/liliCommercial medical device manufacturing experience.br/liliExperience producing implants, grafts, stents, or other implantable products.br/liliProduct inspection or quality control experience.br/liliEnglish and Dutch language skills.br/li /ulbrbWhat we offer /bbrullibr/liliCompetitive salary depending on experience.br/liliPermanent position within a rapidly growing MedTech company with a CE-marked product and a clear commercial roadmap.br/liliA brand-new, state-of-the-art production facility at High Tech Campus Eindhoven.br/liliClear career progression.br/lili25 vacation days.br/liliPension scheme.br/liliTravel allowance.br/liliAn international and collaborative working environment where your craftsmanship is seen.br/li /ulbrbAbout Xeltis /bbrpXeltis is a leading medical technology company developing restorative vascular implants based on Nobel Prize-winning supramolecular chemistry. Our innovative devices enable the body to regenerate living tissue and restore natural function. /pbrpWith CE marking achieved for our aXess™ vascular access graft, Xeltis is entering an exciting phase of commercial growth. The products that change patients’ lives are manufactured right here in Eindhoven. /pbrbApplications /bbrpApplications in Dutch are also welcome. xgiwjmb /pbrpbAcquisition by recruitment agencies is not appreciated. /b /pbr