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Quality and Regulatory Project Lead
- Quality Assurance and Regulatory Affairs, Medical Device, CFR 820 & ISO 13485
- Project Lead, Quality Management Systems
About Our Client
Our client is a world leader in health solutions. They offer a comprehensive range of medical devices, health technologies and much more. This technology company has the mission to improve people's life with their innovations.
The Innovation Site from our client is leading innovative product development for multiple business groups such as Personal Care or Health and Wellness.
The project is to embed QA and RA requirements into new process designs, confirm that QA and RA controls are tested in the software validation of the project or included in the instructions of the new processes. Once all the software is validated, processes are designed and documents are released, you will create quality transition plans for the deployment to markets of Medical Devices. These plans will be communicated to the local QA and RA leaders for them to take action.
Project Teams include cross functional Local Business (including Q&R) and End to End (E2E) representatives (including E2E Q&R), covering moving from Legacy to Future E2E state for Processes and SW Tools.
Your main responsibilities as a Quality and Regulatory Project Lead:
- Manage the program and/or project as it applies to effect on Quality Management System through use of Quality Plan(s)
- Work with program and project teams, including Subject Matter Experts (SME), from the business and QA/RA to perform the review and incorporation of Quality System Regulations into the processes down to the level of work instructions
- Work with same program and/or project teams on supporting user requirement definitions, etc. in support of the software tool(s) that support the procedures
- Support the teams to ensure the "How" aspects to be built into the procedures, instructions, templates, etc. include applicable quality system regulations that apply to Quality Management System (QMS)
- Create write, update & maintain Quality Plan(s) in conjunction with the teams and QA, to meet program/project planning
- For Project teams, support GAP analysis of Legacy vs. E2E processes and procedures
Support the Project teams by communicating visibility as regard to:
- The process gaps between configured enterprise applications and compliance requirements.
- Alignment between the quality plan(s) and deployment plans in respect of legacy / transition / future (PIL) application landscapes
The Successful Applicant
- Bachelor degree or Master degree with 7+ years of relevant experience
- Experience with medical devices
- Knowledge of CFR 820 & ISO 13485.
- Knowledge of Quality Management Systems
- Project management
- Experience with writing quality plans
What's on Offer
- Hourly tariff between € 70 and € 87, depending on experience and availability