Design Quality Lead

Roles & Responsibilities

• Serves as the primary quality lead for project activities to achieve on‑time quality deliverables, high customer value, and profitable results. Primary driver for the quality and compliance aspects of the project.
• Assures proper integration and support of device regulations, drug regulations, and as appropriate, biologics regulations. Responsible for compliance with company policies and procedures.
• Ensures design control documentation (traceability/linkages) and design change control requirements are met. Assesses the impact of a change on the safety and efficacy of the combination product/device. Analyzes and justifies the impact on cumulative changes.

• 5+ years of total combined experience, with at least 3 years in Device Design Quality Assurance.
• Deep understanding of DHF structure and traceability between DHF elements.
• Knowledge and a comprehensive understanding of combination products, medical devices, and design controls.
• Sound technical understanding of product development (e.g., approaches for definition of requirements and specification setting for verification and validation) and/or practical experience in design control.
• Well‑versed in risk‑management methodologies and their application.
• Ability to work independently and in a global team environment, and with all levels of personnel within the organization.