Principal Specialist - Quality Assurance (Design)
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
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