Quality Engineer

04.112024 Quality Engineer (80-100%) Limula SA is a Life Science Tools company based in Lausanne, Switzerland. Our mission is to make highly personalised cell therapies accessible to the patients in need, at reasonable cost, wherever they are. To achieve this goal, our multidisciplinary team provides an innovative manufacturing platform that enables the production of these ‘living treatments' at scale, through automation. We have the ambition to grow our team with a proactive approach to excellence and diversity, adding more passion and know-how with every individual we bring on board. Quality Engineer (F / M, 80-100%) LOCATION : Biopôle, Epalinges, SwitzerlandSTART DATE : 1 SEPTEMBER 2024 or later You want to discover what it is like to work in a fast-paced, mission-driven start-up environment? You have the ambition to contribute to an ambitious project while learning new skills? You are flexible and dedicated, ready to tackle challenges and be rewarded with opportunities? This role is for you! Position Summary To support Limula in its mission to make Cell and Gene Therapies accessible to patients, you will support the Chief Operations Officer in the implementation and maintenance of the company quality management system (QMS), and perform and contribute to the quality related tasks during the whole product life cycle. Responsibilities Champion a culture of quality : promote a culture of quality across the company, provide guidelines, and train other team members on procedures QMS implementation : lead the development of SOPs and related templates Product Development : lead development, review and approval of documentation related to new product introduction and support the Limula team in their adoption. V&V, Process & SW-validation Supplier Quality Management : support the Limula team with supplier qualification, continuous monitoring and evaluation, including supplier audits Quality Controls and product release : support Limula with the quality controls activities e.G. Incoming goods and final product inspection (IQC & FQC) and product release Risk Management : support the team with product risk analysis, dFMEA and pFMEA Internal Audit : establish and perform an internal audit program Equipment Management : manage the calibration and maintenance of all Limula equipment CAPA and NC : manage product non-conformities, corrective and preventive actions, including those from suppliers. Establish complaints procedures of Limula products Requirements M.S Degree in business, science or technology Minimum 2 years working in quality roles in the life science or medical device industry In-depth knowledge of ISO 13485 : 2016 and / or ISO9001 Prior experience in implementing and managing a QMS Prior experience with new product introductions and / or supplier management and / or manufacturing and / or product development Excellent verbal and written communication skills in English Preferred Qualifications M.S Degree in Biomedical Engineering or related field Experience with Project Management and / or working in a start-up environment, ideally in a company developing or supplying Life Science Tools Good knowledge of ATMP / GMP regulations, particularly as applied to cell therapy Good knowledge of medical device or laboratory equipment standards, e.G. ISO 61010-1 / ISO 60601-1 Good knowledge of the Low Voltage Directive (2001 / 95 / EC) Good knowledge of FDA 21 CFR 820 QSR (cGMP) Soft Skills Proactive and autonomous Strong sense of responsibility Attention to details, analytical and structured work, problem-solving skills Sustained capacity to meet deadlines and coordinate with others "Roll up your sleeves" attitude, ability to work in a multidisciplinary, multinational team Ability to organise, prioritise, balance risks and handle multiple projects / activities in parallel Good communication and influencing skills Benefits Company mission that aims to impact the lives of patients with life threatening conditions Innovative and multidisciplinary project, at the interface between engineering and biology An opportunity to work in the Cell and Gene Therapy industry, one of the most exciting and fast-growing medical fields Fast-paced, highly stimulating startup environment with a collaborative atmosphere Unique opportunity to join a company at an early stage, with avenues for career development and personal growth Competitive salary, with additional advantages and incentives including a fully funded pension Respectful and equal opportunity work environment, in a world-class location Submit your resume and a motivation letter for this position, in a single pdf file. Interviews will be scheduled on a rolling basis, so don't delay! To apply, or to request more information, please contact : Dr. Thomas Eaton, COO #J-18808-Ljbffr