1-2 years experience in Quality Assurance and Regulatory Affairs for Medical. Devices / In Vitro Diagnostics Medical Dev
OPEN POSITION QA/RA Responsible Job title Role
Quality Assurance and Regulatory Affairs Responsible Manage and Maintain our Quality Management Systems. Ensure Lunaphore products meet all necessary regulatory requirements.
Starting date Position type
Permanent, full-time. December 2016
Lunaphore Technologies is a young start-up company active in the In Vitro Diagnostics (IVD) field developing a product based on a microfluidic technology to analyze tissue samples for cancer diagnostics. In order to develop the company and product properly, Lunaphore is seeking a highly motivated candidate to join our team for a permanent full-time position in our offices at EPFL Innovation Park and contribute to our company with his/her experience in quality assurance and regulatory affairs.
Key responsibilities The QA/RA Responsible reports directly to the COO and is in charge of managing all quality and regulatory related tasks. You will: Implement and maintain the Quality Management System (QMS) of the company in compliance with ISO9001 and ISO13485. Manage and establish compliance of the IVD product with regulatory and clinical requirements. Be responsible for keeping quality and regulatory-related deadlines for the company as well as ensuring up-to-date documentation. Conduct internal audits. Coordinate and manage external audits. Conduct trainings to new employees or when new quality procedures are being implemented. Lunaphore Technologies, EPFL Innovation Park, Building C, CH-1015 Lausanne www.lunaphore.com
Frequently interact with the R&D team to ensure compliance of the product development to regulatory and quality requirements. Report to the COO on a regular basis. Manage contacts with external parties such as notified body, competent authorities or consultants. Drive for results by consistently achieving goals and pushing to complete tasks by their deadlines.
Skills You have an excellent understanding of quality and regulatory standards. You have the ability to adapt in a constantly changing environment. You like to interact with people in a multi-disciplinary environment. Excellent organizational skills, attention to detail, ability to manage deadlines, multiple priorities, and deliver results with limited supervision. You have experience with implementation or maintenance of a Quality Management Systems and performing audits. You have experience with In Vitro Diagnostics regulatory requirements. An excellent command of written and oral English. French is a strong plus. You have excellent knowledge of Microsoft Office software programs (Word, Excel, PowerPoint).
Preferred qualifications A degree in a related field and/or a certificate in Quality Assurance and Regulatory Affairs. 1-2 years experience in Quality Assurance and Regulatory Affairs for Medical Devices / In Vitro Diagnostics Medical Devices.
We offer A young and strongly growing high-tech start-up An international working environment with high level of diversity and strong network. A highly interactive team with strong personal and technical qualities
Contact information If you are interested, send your application to:
[email protected]
Lunaphore Technologies, EPFL Innovation Park, Building C, CH-1015 Lausanne www.lunaphore.com
