Description:
This is the Design Quality Assurance Team that is incredibly talented, dedicated, and all about the Team. This is an exciting role in a fast-paced environment directing the development and implementation of the organization’s quality assurance policies and programs related to Research and Development across multiple sites. The Team will be focused on lean compliance, excellent design transfer into high-volume manufacturing across the globe, to deliver high-reliability products to all the customers and partners that we serve. You will also be collaborating with the Advanced Research Team and next-generation technologies.
Where You Come In
- You will lead all aspects of the Design Assurance and Control process, including Development Quality Engineering, Software Quality Engineering, Product Reliability and Risk Management. Oversee performance and resource allocation across multiple sites.
- You will collaborate closely with R&D and many other cross-functional teams throughout the development lifecycle, including design transfer and commercialization.
- You will leverage customer and consumer feedback to drive continuous improvement initiatives aligned with departmental and corporate strategic goals.
- You will ensure compliance with applicable quality, environmental and safety regulatory, including FDA Quality System Regulation (QSR) as they evolve, and Dexcom’s portfolio of products continues to grow.
- You will promote cross-functional understanding and adherence to quality standards and regulatory requirements.
- You will represent the organization during regulatory audits and inquiries, clearly articulating technical details of product design, verification strategies and Design History Files.
- You will manage and track team activities, ensuring milestones are achieved within defined budgets and timelines.
What Makes You Successful
- You have proven experience in Design Quality Assurance within the medical device industry.
- You must have Class II medical devices experience.
- You must have a minimum of 12 years of experience in medical device development.
- You bring at least 7 years in progressively responsible leadership roles.
- You demonstrate an ability to adapt to shifting priorities and manage multiple initiatives.
- You possess strong interpersonal, written, and verbal communication skills.
- You are self-motivated with a collaborative and proactive approach.