pHave you ever dreamed of working for a company that puts people at the heart of its DNA? /ppAre you ready to make a difference? /ppAre you excited about collaborating and sharing your expertise with leaders in our industry? /ppYES? SO ARE WE! /ppGXP CONSULTING Switzerland is a Swiss company made up of a passionate team of life-science professionals. Since 2014, we have been providing our clients with cutting-edge expertise and support covering the entire product life cycle. /ppJoin a team where your skills will have a real impact on patients’ lives. /ppGXP Consulting Switzerland is growing its MedTech Combination Products team. We're looking for experienced professionals to join demanding drug-device development projects (autoinjectors, prefilled syringes) with leading pharma clients in the Basel area. /ph3What You'll Do : /h3h3Design Control Quality Oversight /h3ulliAct as quality owner of design control activities across development and industrialisation, ensuring compliance with 21 CFR 820 / QMSR, 21 CFR Part 4, ISO 13485 and EU MDR Art. 117. /liliReview and approve Design History File deliverables, including the design plan, design inputs, specifications, traceability matrix, verification and validation protocols and reports. /liliParticipate in design reviews as the independent quality reviewer and ensure that phase-gate deliverables are complete and compliant. /liliEnsure design outputs are properly transferred into the Device Master Record and manufacturing documentation. /li /ulh3Profile : /h3ulliMaster’s degree in Engineering, Life Sciences or equivalent. /lili5+ years of experience in device quality within a GMP/QMS environment, ideally on combination products (autoinjectors, prefilled syringes, pen injectors). /liliSolid knowledge of ISO 13485, ISO 11608, MDR and FDA design controls / combination product requirements (21 CFR 820 / QMSR, Part 4). /liliHands-on experience with FMEA, change control, investigations and CAPA. /liliAbility to bridge pharma and device cultures and to act as a credible quality partner for RD and manufacturing. /liliFluent English; French or German is an asset. /li /ulh3About us : /h3ulliHuman-sized company with great colleagues from a large diversity of cultural and professional backgrounds /liliWe do care about our people, communicate openly and value feedback /liliWork as a team where every member is valued and appreciated /liliOpportunity to contribute to ambitious projects within an international and multicultural environment that fosters innovation, collaboration, and professional growth. /liliContinuous learning and development opportunities via internal or external training and workshops /liliCompetitive salary package in line with industry practice together with exceptional employment benefits /li /ulpAt GXP Consulting Switzerland everyone contributes to our joint success and grows individually! /p #J-18808-Ljbffr
Device Quality Engineer Arbeitgeber: Gxp Consulting Switzerland
GXP Consulting Switzerland ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern nicht nur ein wettbewerbsfähiges Gehalt bietet, sondern auch vielfältige Entwicklungsmöglichkeiten in einem dynamischen und kooperativen Umfeld. Unsere Unternehmenskultur fördert Teamarbeit und Innovation, was es Ihnen ermöglicht, Ihre Fähigkeiten als CSV Validation Engineer in der pharmazeutischen und biotechnologischen Branche weiterzuentwickeln und einen bedeutenden Beitrag zu leisten.
Kontaktdaten:
Gxp Consulting Switzerland Recruiting-Team
