Verification and Validation Expert in Drug Delivery Devices (m/f)

REFERENZNUMMER:

278274/11

IHRE AUFGABEN:

-Lead and manage the end-to-end test activities related to medical drug delivery devices to ensure that the final product meet the intended use
-Define verification and validation strategy for drug delivery devices
-Define the end-to-end system test requirements of projects, ensuring traceability and testing of all design inputs and critical product features
-Review and approve supplier test plans, protocols and reports
-Develop and execute medical device system verification and validation protocols and scripts
-Setup a defect and test management tool
-Plan and implement quality assurance and quality control for all test activities related to a project
-Manage all test activities related to a project in term of resources, timing, costs, quality and risk
-Generate verification and validation report summaries and known anomalies issues
-Communicate effectively with clients and team members, at all levels of the organisation to solve complex project business, clinical and technical challenges, using written and verbal communication

IHRE QUALIFIKATIONEN:

-Master's degree (or equivalent) in mechanical engineering or electronic engineering
-Training with regard to software development life cycle, preferably in the medical device domain (21 CFR 820, IEC 62304, FDA software guidelines ISO 13485 and ISO 11608)
-In depth experience in V and V of complex medical device development, including electronic and mechanical elements
-Experience in working within a regulated medical device development environment, particularly based on the FDA Quality System Regulation and ISO 13485
-Excellent interpersonal skills and team spirit with the ability to resolve conflicts and motivate others
-Leadership skills and ability to secure commitment from other stakeholders
-Excellent communication skills
-Knowledge of medical drug delivery devices with embedded software is beneficial
-Fluency in English, knowledge of French or/and German is of advantage

WEITERE QUALIFIKATIONEN:

Qualification/validation specialist