Quality System Management Intern for medical device startup

Do you want to start your career as a Quality Management Professional in the medical device industry Are you passionate about highest quality standards Become a Quality System Management Intern at Odne!

About us

Odne founded as Lumendo in 2018 and ISO 13485 certified aims to disrupt the endodontic device market in the US and EU. Our mission is to develop the most advanced solution for this very challenging dental procedure with a disruptive cleaning technology and a novel lightactivated filler thus helping people to keep their natural teeth longer.

Job description

This internship offers a deep insight into Quality Assurance Quality Control Regulatory Affairs Risk Management and all Quality Management processes. You will work at the interface of development production supply chain and postmarket activities and deepen your understanding of all quality relevant procedures at Odne AG. You will assist the quality manager in maintaining and improving the quality management system specifically to the US requirements (21 CFR 820 and related). You will learn from experienced professionals throughout the company acquire valuable skills and knowledge in quality system management and medical device regulations while contributing to the continuous improvement of our QMS and products.

The position allows you to quickly gain responsibility in managing parts of our quality processes such as equipment qualification or validation projects. After thorough training you will be able to manage Quality Events through the whole organization together with various stakeholders.

Tasks

• Assist the Quality Manager in implementing maintaining and improving the quality management system according to 21CFR 820 ISO 13485 MDR and other applicable standards and regulations
• Support the quality and regulatory activities related to clinical investigations and evaluations product development risk management and postmarket surveillance
• Gain responsibility in various qualification and management activities such as equipment and supplier qualification and management
• Participate in internal and external audits inspections and reviews
• Document and update quality processes procedures records and reports
• Perform quality checks tests and validations on products and processes
• Identify and report quality issues nonconformities change requests CAPAs and feedback. After thorough training you will be able to handle quality events independently.
• Collaborate with crossfunctional teams and stakeholders to ensure quality compliance and customer satisfaction

Requirements

• A degree in science or engineering or a comparable background
• A strong interest and motivation in quality management and regulatory affairs in the medical device industry
• A willingness to learn and grow as a Quality Professional
• A high level of attention to detail accuracy and reliability
• Excellent communication documentation & organizational skills. Proficiency in MS Office and high IT affinity
• Fluency in English both written and spoken. Knowledge of German and/or French is an advantage
• A highly motivated outgoing and responsible personality with a wellorganized working style.

Benefits

• Work in a dynamic innovative and supportive environment. As a startup we will give you high responsibilities big learning opportunities and lots of freedom in organizing your work.
• Gain valuable experience and exposure to various fields in the medical device industry such as Regulatory Research and Development Supply Chain Management Marketing Management Scientific and Clinical Affairs
• Be part of an important interdisciplinary interface function and feel that your work matters and improves peoples life.
• Have the opportunity to stay after the internship and become a valuable member of the team being an expert on processes process documentation interfaces and our products
• A young entrepreneurial international and motivated team of 10 people.
• Intensive onboarding and subject training to quickly gain knowledge and handson experience of the applicable norms and regulations: 21 CFR 820 ISO 13485 ISO 14971 ISO 10993 IEC 62366 EU MDR.

We look forward to receiving your full application including CV and cover letter stating your availability.

We guarantee an efficient & fair hiring process. Please note that for legal reasons we can only consider candidates of CH or EU nationality or candidates with a valid Swiss work permit.