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Senior quality engineer

Kreuzlingen
medtechrec Jobs
Ingenieur Qualitätssicherung
Inserat online seit: 28 Januar
Beschreibung

Responsibilities:

* Technical project management for development projects (scope, timeline, budget, resources, risks, deliverables)
* Experience in the development/optimization of ceramic implants and leading interdisciplinary teams (R&D, QA, RA, production, purchasing, suppliers, external partners) including meeting moderation, decision gates and stakeholder reporting.
* Hands-on development of products/components: concept, design, prototyping, test planning and technical evaluation
* Responsibility for end-to-end design control (e.g., ISO 13485)
* Coordination of laboratory and testing activities (mechanics, fatigue strength, material/surface characterization, and, if necessary, biocompatibility in consultation)
* Support with root cause analyses and CAPA-related activities in collaboration with QA
* Experience with ISO risk management), MDR/CE, and possibly FDA/21 CFR 820.
* CAD experience and technical understanding of tolerance management and manufacturing processes
* Experience in dental/implantology (compatibilities, interfaces, clinical requirements)

Requirements:

* Completed studies in mechanical engineering, medical technology, materials engineering, plastics/ceramics technology or similar.
* Several years of experience in product development (ideally MedTech/Dental)
* Experience in project management (internal/external), including planning, control and stakeholder management
* Very good understanding of design control and technical documentation in a regulated environment (ISO 13485 / comparable)
* Experience with verification/validation, testing methods
* Structured, independent and goal-oriented work style
* Reliability, accuracy and a strong commitment to quality
* Strong communication skills (German & English)

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