R&D Engineer - Quality Assurance (w/m/d)

We are Vantive, a new independent health company focused on vital organ therapies. Over the past seven decades, we have created a wealth of outstanding products for the treatment of kidney diseases. We are now strengthening our commitment by improving the experience of patients and professionals in the field of dialysis through digital solutions and advanced service offerings and at the same time developing our organ-supporting therapies beyond the field of kidney treatment.

At the Gambro Dialysatoren GmbH site, we specialize in the development and production of innovative dialysers and dialysis catheters within the Vantive Group. Around 1,100 highly qualified employees are committed to improving the quality of life of patients with kidney disease or kidney failure.

In this position, you have the opportunity to perform product quality activities in the areas of New Product Development (NPD), Sustaining Engineering (SPO) and Regulatory Compliance for dialysis filter disposables, based on the project orders received by the Product Quality Manager.

Tasks Member of the project core team for new product developments and design changes as product quality manager/r Product quality activities within the framework of New Product Development (NPD), Sustaining Engineering (SPO) and Regulatory Compliance for dialysis filter disposables, based on the project orders received by the Product Quality Manager Checking documents to create and maintain the Design History File Ensuring compliance with existing Vantive business practices and all local work instructions and applicable laws and standards Ensuring the consideration of complaint data and CAPA measures of current products in SPO activities Cooperation and support of other business departments in preparing audits (internal and external) Regular reporting to the Product Quality Manager on the status of activities under his/her responsibility

Graduate degree, preferably in engineering (medical engineering, life science engineering) or in the scientific field (chemistry, biology) At least 2-3 years of professional experience in the field of Med-Tech, focusing on the quality of medical devices and experience in Design Control Knowledge and experience on quality management requirements based on ISO13485, FDA, CFR, GMP Regulation and MDSAP Knowledge of risk management principles Critical thinking, problem-solving orientation, cooperation, flexibility, communication and negotiation skills Flowing German and English skills

Engaged and gifted people offer interesting opportunities in every phase of professional life. Gender, age, skin color, origin, sexual orientation and impairment play no role in this - on the contrary: we promote diversity and believe that diversity is an enrichment. We offer comprehensive training opportunities as well as a high level of experience from the expertise of the local and international teams.

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