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Principal Specialist

2 weeks ago

North East, United Kingdom EPM Scientific Full time

Principal Specialist - Quality Assurance (Design) Newcastle Upon Tyne, England, United Kingdom This range is provided by EPM Scientific. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Our client is an international life sciences organisation bringing life‑changing medical diagnostic products to market. They are looking to add a Principal Specialist Quality Assurance (Design) to an existing team focused on developing diagnostic solutions to accelerate next‑generation, life‑changing therapies/products. The Principal Specialist will be responsible for delivering diagnostic assays to market. Responsibilities Work on site projects to support the progression of the most viable commercial or 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, PMAs and IVDR CE certifications. Skills and 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 21 CFR 820, ISO 13485, ISO 14971 and MDSAP. Ideally a degree in a relevant field or medical/technical field and experience in medical device Quality Assurance. Ability to work onsite and travel when required. Nice to Have Experience in delivering higher classification medical devices and/or companion diagnostic products to market. Supplier auditing and/or quality assurance experience. Experience with the MDSAP programme. Our client will offer sponsorship for EU citizens that have all the skills mentioned above. Seniority level Mid‑Senior level Employment type Full‑time Job function Quality Assurance and Research #J-18808-Ljbffr