Job Description
Our client an international life sciences organisation bringing life changing medical diagnostic products to market are looking to add a Principal Specialist Quality Assurance (Design) to an existing team.
They are a global leader with a comprehensive portfolio, and you will be joining a team developing diagnostic solutions to aid the acceleration of next-generation, life-changing therapies/products.
The Principal Specialist Quality Assurance (Design) will be responsible for delivering diagnostic assays into the Market.
Responsibilities:
* Work on site projects to support the progression of the most viable commercial/strategic opportunities for New Product Development (NPD) or Product Lifecycle Management
* Provide Design Control leadership across or within function, working with other sites
* Work independently and with project team members to develop and improve processes to reduce variability and increase robustness throughout the development and product lifecycle for multiple projects
* May lead functional teams or projects with moderate resource requirements, risk, and/or complexity
* Work closely with Regulatory Affairs on deliverables for global regulatory submissions, including FDA 510(k)s and PMAs and IVDR CE certifications
Skills/Qu...