Principal Specialist – Quality Assurance

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

Desired Skills and Experience
Design/Development, IVD, medical device, quality systems, 21 CFR 820, ISO 13485, ISO 14971