Quality Manager for Medical Device Startup
vor 1 Woche
About us
Lumendo is a spin-off from ETH Zürich and EPFL Lausanne and wants to set a new standard of care for dental root canal treatment.
disruptive cleaning technology and a novel, light-activated filler, thus helping people to keep their natural teeth longer.
We have developed the products since 2018 and are going to launch them in the US in 2024. As a medical device manufacturer, Lumendo is operating under an ISO13485-compliant QMS. The products are classified as class II / 2a.
Your job description
Your ambition is to assure that all Lumendo products are safe & effective for the patient.
To do so, you implement effective quality measures throughout the product lifecycle, from development to production, supply chain and post-market activities.
Your responsibility is to maintain and strengthen the quality management system and coordinate the interaction with our notified body and the FDA.
Furthermore, you will manage the technical files for Lumendo's products and support the development team in creating the design history files.
Following the FDA clearances in 2023, the position allows you to gain responsibility in managing our quality processes on a broader level, including further market expansions into Europe in 2025, the middle east and Asia in 2026, until the transfer and integration of the quality management system to a larger acquirer, currently planned for 2027.
You will work together with the engineers, dentists, clinical and regulatory specialists, manufacturers and suppliers, who have developed the products and processes.
Tasks
- Maintain, improve, and verify the effectiveness of Lumendo's QMS according to ISO 13485 & 21 CFR 820.
- Conduct management reviews, supplier audits, internal audits, and trainings.
- Manage interaction with our notified body and the FDA for audits and inspections.
- Manage the technical files of Lumendo's products in accordance with EU MDR and FDA requirements.
- Handle nonconformities, change control, CAPAs, complaint, feedbacks and vigilance.
- Review design and manufacturing records and ensure compliance to the norms and regulations.
- Assist design review, risks management, usability engineering and clinical evaluation activities and provide your feedback from the quality perspective.
Requirements:
- Background in science or engineering and at least 3 years work experience in the medical device industry.
- Experience in quality management for medical devices, ideally in formulationbased and/or active devices.
- Expert knowledge and handson experience of the applicable norms and regulations: EU MDR, ISO 13485, 21 CFR 820, ISO 14971, ISO 10993, IEC 6236
- Ensures quality and safety of our products, supporting in the overall success of the company.
- Ability to create documentation efficiently. Excellent mastery of the English language.
- Highly motivated, outgoing, entrepreneurial, and responsible personality; wellorganized working style.
Benefits:
A work that matters and can help improve people's life.
A startup environment, giving you high responsibility, big learning opportunities and lots of freedom.
A young, entrepreneurial, international and motivated team of 10 people.
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