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Join VitalPath in New Hope as a Design Assurance Manager! About VitalPath VitalPath is a trusted partner in the catheter design and manufacturing of custom medical devices that save lives and restore patient health and vital function. We re excited about this important work and bring vital energy to our customer partnerships. In our growing organization it s important that we continue to offer a small-company, family-oriented environment with competitive pay and benefits. If you want to make a difference in people s lives and be a part of a friendly, fun place to work with people that value diversity, come join our team! About the Position The Design Assurance Manager manages all quality and compliance aspects of the New Product Development System. The Design Assurance Manager will be responsible for ensuring the design and development of medical devices comply with regulatory standards and quality requirements. This role involves leading design assurance activities, including risk management, design verification and validation, and ensuring adherence to design controls throughout the product lifecycle. This position additionally provides overall leadership of the site s quality efforts and oversees all aspects of its Quality System including acting as the site s Management Representative. Responsibilities Lead the design assurance activities for new product development projects, ensuring compliance with FDA, ISO, and other applicable regulatory standards. Develop, implement, and maintain design control procedures to ensure robust product design and development processes. Oversee risk management activities, including the development and maintenance of risk management files (e.g., FMEAs, risk assessments). Coordinate design verification and validation activities, including protocol development, execution, and reporting. Review and approve design control documentation, including design inputs/outputs, design reviews, and design history files. Collaborate with cross-functional teams, including R&D, Quality, Regulatory, and Manufacturing, to ensure seamless integration of design assurance activities. Lead and facilitate design reviews to ensure design robustness and compliance with regulatory requirements. Monitor and analyze design and development trends to ensure continuous improvement of design assurance processes. Provide training and guidance to team members on design assurance principles and practices. Plan, schedule, and manage product quality control activities to ensure production is consistent with established standards and customer specifications. Establish and monitor Key Performance Indicators for trends and improve metrics related to yield, nonconforming product, CAPA, audits and customer complaints. Serve as the Management Representative for ISO 13485:2016 and 21 CFR Part 820. Ensure that processes needed for the Quality Management System (QMS) are established, implemented, and maintained. Ensure that the performance of the QMS is reviewed at planned intervals to ensure its continuing suitability, adequacy, and effectiveness. This review means assessing opportunities for improvement and the need for changes to the QMS. Ensure that records are established and maintained to provide evidence that the QMS is being followed and that there is a system in place for the identification, storage, protection, retrieval, retention time and disposition of such records. Manage and maintain all aspects of the quality system to support the design, development, manufacturing, and distribution of medical devices/products. Identify and prioritize complaints and handle CAPA systems, ensuring investigations, root cause determination, implementation, and effectiveness checks are adequately addressed and documented in a timely manner. Communicates objectives, impacts and expectations of quality improvement action plans to management team, task force and production team.