Description
We are looking for a
Verification and Validation Expert in Drug Delivery Devices (m/f)
Reference: -en
Start: asap
Duration: 5 MM
Place: in Aubonne
Branch: Wettbewerber
Your tasks:
- 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
Your qualifications
- 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
Skills:
- Qualification/validation specialist