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/Qualifications:
* Design Controls & Design/Development practices for regulated products
* Expertise with IVD medical device new product development and design controls
* Knowledge of international IVD medical device quality systems including but not limited to 21 CFR 820, ISO 13485, ISO 14971 & MDSAP
* Ideally degree in relevant field or medical/technical field or responsibility in medical device Quality Assurance
* Ability to work onsite and travel when required
Nice to have:
* Experienced in delivering higher classification medical devices and/or companion diagnostic products to market
* Supplier Auditing and/or Quality Assurance
* Experience with the MDSAP Programme
Our client will offer sponsorship for EU citizens that have all the skills mentioned above
Desired Skills and Experience
Design Assurance, Design Control, IVD, medical device, quality systems, 21 CFR 820, ISO 13485, ISO 14971