Quality Manager for Medical Device Startup
vor 2 Monaten
Want to have an impact on the life of hundreds of millions of patients? Become the quality manager at Lumendo
About us
Lumendo, founded 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, light-activated filler, thus helping people to keep their natural teeth longer.
Job description
Your ambition is to assure that Lumendo’s 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. You are responsible to maintain, strengthen and extend the existing quality management system across all functions and systems and coordinate the interaction with our notified body and the FDA. You maintain and develop the technical files of our 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 are comfortable working in a multinational team of engineers, dentists, clinical and regulatory specialists, and contract manufacturers. As a quality manager, you enjoy being the backbone of the company.
Tasks
- Maintain, improve, and verify the effectiveness of Lumendo’s QMS according to ISO 13485 & 21 CFR 820.
- Handle non-conformities, change control, CAPAs, complaint, feedbacks and vigilance.
- Conduct management reviews, audits, and trainings.
- Manage interaction with our notified body and the FDA.
- Review design and manufacturing records and ensure compliance to the norms and regulations.
- Manage the technical files of Lumendo’s products in accordance with EU MDR and FDA requirements.
- 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 formulation-based and/or active devices.
- Expert knowledge and hands-on experience of the applicable norms and regulations: EU MDR, ISO 13485, 21 CFR 820, ISO 14971, ISO 10993, IEC 62366.
- 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; well-organized 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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