Software Quality
il y a 22 heures
Software Quality & Risk Engineer M/F Software Quality & Risk Engineer permanent position is based in Meylan (nearby Grenoble). Your role As part of Kayentis Quality & Regulatory team, you contribute to the quality and reliability of Kayentis Solutions by ensuring development activities are carried out in accordance with regulatory requirements applicable to computerized systems used in clinical investigations. Responsibilities Participate in the maintenance, continuous improvement, and training of processes related to the design and development of Kayentis Solutions and Services, including consideration of electronic records and electronic signatures requirements (21 CFR Part 11) and IT interfaces. Maintain the Validation Master Plans of Kayentis solution and interfaces, and Kayentis business tools. Perform a quality review of development deliverables prior to release. Participate in the maintenance and continuous improvement of IT processes. Maintain Kayentis risk management and validation processes. Train and coach teams on Kayentis Quality Management System processes and applicable requirements. Support quality processes as applicable to the development and IT processes, including internal and client audits; qualification, monitoring and audits of applicable suppliers and subcontractors; validation of computerized systems. Qualifications Master degree level or equivalent in quality, risk management, or software engineering. Professional experience > 5 years in life science or medical technology development. Good verbal communication and writing skills in French and English. Customer‑oriented. Interest in team leadership or prior experience in coaching or managing others is a strong asset. Preferred Experience in the pharmaceutical, medical device, or clinical field. Experience with risk management standards such as ISO 14971. Thank you for applying via LinkedIn rather than by email, as it ensures optimal processing of your application. Seniority level Mid‑Senior level Employment type Full‑time Job function Engineering and Quality Assurance Industries Pharmaceutical Manufacturing and Software Development #J-18808-Ljbffr
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