Principal Specialist - Quality Assurance

Our client an international life sciences organisation with a commitment to innovate and bring life changing medical diagnostic products to market are 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 advance 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