Overview
Our client, an international life sciences organisation, is looking to add a Principal Specialist Quality Assurance 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 will be responsible for delivering and advancing staining reagents and 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
* Knowledge of 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 and experience with increasing responsibility in medical device Quality Assurance.
* Ability to work onsite and travel when required (up to 20%).
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.
Additional Information
Location: Newcastle Upon Tyne, England, United Kingdom. Travel up to 20% may be required. Job postings from EPM Scientific may include additional context and candidate suggestions. Referrals can increase your chances of interviewing at EPM Scientific.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Quality Assurance and Research
Industries
* Medical Equipment Manufacturing
* Pharmaceutical Manufacturing
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