Dir,Design Quality Assays
Business Unit: Diagnostics
Requisition Number: 240353
Primary Location: United States-New York-Tarrytown
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Master's Degree
Travel Required: 10%
Director Design Quality Assays
An expert providing technical leadership, knowledge and experience by overseeing control system development and design controls in new assay product development. The incumbent works with R&D and Manufacturing to create a control system ensuring that our products meet customer, regulatory and manufacturing requirements over the life of the product. Ensure that assay PDP teams meet the intent of regulations, standards and internal procedures to achieve compliance. The function has significant strategic impact on the overall success of the LD business. Will lead compliance improvement culture change in R&D.
Create, implement and assure sustainability of best practices in new assay control system development and compliance to Design Control regulations.
Directs complex technical activities and provides recommendations regarding assay design choices.
Directs the development and monitoring of quality metrics for Design Quality.
Resolves extremely complex problems across multiple departments, functions and sites.
Provides training in Design Control and control system development to relevant LD staff.
Successfully defines work flows, jobs and reporting relationships to obtain optimum effectiveness.Specific qualifications required:
Expertise in reagent product development for diagnostic products. PhD or MS degree in the sciences and 15+ years of experience. Experienced and knowledgeable in Design Control regulations.
Experienced in techniques driving to root cause.
Sound knowledge of data analysis with detailed understanding of precision and bias analyses.
Ability to understand complex issues and translate into operable experiments and solutions leading to robust linkages between optimizations, design spaces and control system specifications.
- Ability to work independently and in project teams.
- Excellent communication skills (written and spoken)