Tasks:

• Maintenance and continuous improvement of the QM system (document change control, handling of non-conformities, etc.)
• Maintenance of technical files.
• Ensuring product conformity to all applicable regulatory provisions before delivery to the customer.
• Advise specialist departments in daily quality-related activities including planning and execution of employee training.
• Performing assessments of documented regulatory requirements and QM system documentation.

Qualifications:

• Effective communication in international and interdisciplinary teams and active listening skills.
• Fluent in English and German.
• At least 2 years of experience in managing QM systems covering ISO 13485, ideally involving development of medical device software.
• Experience in generating and adapting SOPs and Working Instructions together with specialist departments such as Research & Development and Product Management.
• In-depth knowledge of European medical device legislation, especially Regulation 2017/745 as well as German law (MPG, MPSV, HWG).
• Knowledge of ISO 14971, EN 62304, EN 62366 and ideally EN 82304.
• Ideally experience in conducting internal audits.

Expectations & Tasks:

• very good knowledge of JavaScript
• comfortable working with react.js
• CSS/CSS3
• JQUERY
• REST API
• MYSQL and Sequelize knowledge
• Experience with git
• Able to work in an ongoing agile environment
• Team player

Education & Qualifications / Skills & Competences:

• Student at a university or university of applied sciences
• Strong development skills in one (or more) of modern programming languages and frameworks: JavaScript, node.js, js
• Be open to learn and investigate new and changing technologies, frameworks, etc.
• Good communication skills
• English on a professional level
• Passion for HTML and CSS
• Self-initiated and proactive

Why you´ll like it here:

• You´ll work with a young and highly motivated team
• You´ll have the opportunity to actively participate in shaping the digital future and leave a footprint behind
• We would like to give you the opportunity to develop yourself further as a Software Developer, to gain valuable experience and to coach you in achieving your personal goals
• We value our team: We want to build cool things while working alongside great people. We rely on each other while owning our work
• We recognize that there´s no “I” in Team: We are in this together and learn and win as one!
• You´ll get fresh fruits & daily coffee
• You´ll get a takeover opportunity

Do you wanna be part of our success story?
Write an email to jobs@myoncare.com!

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* All your information will be kept confidential according to GDPR guidelines.

We are warmly welcoming students searching for internships, bachelor or master projects. In our small company students can learn many different things and will be included into the development or productions process immediately. We ask for interest in state-of-the-art technology, computer knowledge and interest in medical device development. Contact us, if you are interested!

Write an email to jobs@myoncare.com!

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* All your information will be kept confidential according to GDPR guidelines.