Basic Function and Scope of Position:
This position will lead and/or support in vitro diagnostic (IVD) design and development activities, focusing on driving strategy and documentation requirements throughout the product life cycle process for multiple concurrent projects.
The position will manage design and development plans (DDP), traceability matrices, risk management activities, phase review requirements, design/process/clinical verification and validation plans/protocols/reports, design history file (DHF) compilation, design change, design transfer, and post market surveillance.
The position will support driving continuous improvement of the quality management system.
Ideal candidates will have superior knowledge of design control/product development, risk management, ISO 13485, ISO 14971, 21 CFR 820, IVDD. A Quality Engineering/Quality Assurance background and a strong understanding of medical device design controls in a regulated environment.
Tasks and Responsibilities:
• Provide design control/product development strategy guidance to cross-functional team
• Act as QA lead on project sub-teams (i.e. Operations, Clinical, Development, Commercial, etc.)
• Develop and drive design and development plans (DDP)
• Develop and drive Traceability Matrices
• Coordinate and drive phase deliverables with cross-functional product development team
• Drive documentation requirements throughout product development process
• Manage compliance and completion of DHFs
• Ensure compliance with regulatory requirements and internal policy and procedures
• Assist in ensuring Quality Systems are established, implemented, and maintained in compliance with all appropriate regulatory standards, including federal, state and local
• Coordinates or assists in coordinating regular quality systems meetings reviewing quality metrics
• Participates in Product Quality reviews, management reviews and preparation of quality reports
• Establishes/updates procedures related to the product development process including design control.