ppbSenior Quality Engineer - Design Assurance (m/f/d) /b /ppbContract: /b permanent /ppWe are partnering with an innovative, high-growth bMedTech Scale-up /b developing cutting-edge connected medical devices (wearable hardware + digital health software/app). /ppThey are looking for a bSenior Quality Engineer (Design Assurance) /b to lead Design Controls, Risk Management, and quality compliance throughout the product development lifecycle. /ph3Key Responsibilities /h3ullibDesign Assurance Leadership: /b Drive Design Controls, Risk Management (ISO 14971), Design Reviews, and Design Transfer for new product development and sustaining engineering projects. /lilibTechnical Documentation: /b Review and maintain complete, compliant, and inspection-ready Design History Files (DHFs) and Technical Documentation. /lilibCross-Functional Collaboration: /b Partner closely with RD, Software, Systems Engineering, Clinical, and Regulatory teams from concept through commercialization. /lilibAudit Subject Matter Expert: /b Serve as the Design Assurance SME during Notified Body audits and FDA inspections. /li /ulh3Requirements /h3ullibExperience: /b 5+ years in Quality Engineering or Design Assurance within the medical device industry. /lilibStandards Regulations: /b Strong working knowledge of ISO 13485, ISO 14971, FDA 21 CFR 820 / QMSR, EU MDR, and active/software standards (IEC 62304, IEC 60601, IEC 62366). /lilibTechnical Scope: /b Hands-on expertise in Design VV, DHF management, and change controls for medical hardware and software (SaMD). /lilibLocation Mobility: /b Resident in Switzerland with the flexibility for occasional on-site presence in Neuchâtel. /li /ul /p #J-18808-Ljbffr
Senior Design Assurance Engineer – MedTech (HW & SW) Arbeitgeber: Randstad Switzerland
Unser Kunde, ein globaler Pionier in der Pharmaindustrie mit Sitz in Kaiseraugst, bietet eine dynamische und unterstützende Arbeitsumgebung, die auf Innovation und Zusammenarbeit ausgerichtet ist. Mitarbeiter profitieren von flexiblen Arbeitszeiten, der Möglichkeit, im Home Office zu arbeiten, sowie umfangreichen Weiterbildungs- und Entwicklungsmöglichkeiten, um ihre Karriere voranzutreiben. Die Unternehmenskultur fördert Teamarbeit und kontinuierliches Lernen, was es zu einem hervorragenden Arbeitgeber für Fachkräfte im Bereich klinische Studien macht.
