Innovation/Design Control & Project Quality Engineer
Description du poste
You can find all of our job offers by clicking here:
https://www.teoxane.com/ (https://www.teoxane.com/)
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Teoxane Laboratories were established in Geneva, Switzerland, in 2003. They are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Teoxane strength is to offer a global patient care. Using its products, practitioners can fill all kinds of wrinkles, from the finest to the deepest, to restore youthful volume to the face, and to treat the neck and décolleté, with natural results. The strength of Teoxane is also its human size and independence. Teoxane has total freedom of thought, action and innovation which makes the company unique.
In the frame of the growth of our business, we are looking for an:
Innovation/Design Control & Project Quality Engineer
Main activities
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Act as QA representative throughout the product lifecycle, from design and development to market authorization, post-market activities, and product withdrawal, including design change management.
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Perform operational quality activities from the design phase through completion of Design Transfer.
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Provide Quality support to Design Control stakeholders through daily operational support, coaching, and training to strengthen the Quality culture at Teoxane.
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Contribute to the implementation of Quality by Design (QbD) across R&D projects.
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Actively participate in design risk assessment activities, including risk identification, evaluation, and definition of risk mitigation and control measures.
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Be responsible for the Design History File (DHF) management process, ensuring creation, maintenance, and updates in line with design-related change controls.
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Support regulatory compliance and continuous improvement of the Design Control process in accordance with ISO 13485 and 21 CFR 820, from feasibility through production.
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Ensure proper application of related processes, including Risk Management (ISO 14971) and Human Factors/Usability (IEC 62366), throughout all development phases.
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Participate in audits and inspections as a Subject Matter Expert (SME), support Design & Development audit readiness, contribute to R&D process mapping and risk analyses, and support the Design Control training program.
Your profile
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University degree in Engineering or related field.
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Minimum 7 years of professional experience in the Medical Devices or Pharmaceutical industry, including a minimum of 3 years in R&D Quality Assurance (Design).
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Strong knowledge of ISO 13485, IEC 62366, ISO 14971, and 21 CFR 820, as well as regulatory requirements applicable to medical devices; experience with audits and inspections against these standards is required.
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Knowledge of Quality by Design (QbD).
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Fluent in English, French is an asset.
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