Dexcom Corporation is looking to solve the problem of improving human health by developing solutions for serious health conditions, including diabetes, and becoming a leading consumer health technology company.
Requirements
- Proven experience in Design Quality Assurance within the medical device industry.
- Class II medical devices experience.
- Minimum of 12 years of experience in medical device development.
- At least 7 years in progressively responsible leadership roles.
- Ability to adapt to shifting priorities and manage multiple initiatives.
- Strong interpersonal, written, and verbal communication skills.
- Self-motivated with a collaborative and proactive approach.
Responsibilities
- Lead all aspects of the Design Assurance and Control process, including Development Quality Engineering, Software Quality Engineering, Product Reliability and Risk Management.
- Collaborate closely with R&D and many other cross-functional teams throughout the development lifecycle, including design transfer and commercialization.
- Leverage customer and consumer feedback to drive continuous improvement initiatives aligned with departmental and corporate strategic goals.
- 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.
- Promote cross-functional understanding and adherence to quality standards and regulatory requirements.
- Represent the organization during regulatory audits and inquiries, clearly articulating technical details of product design, verification strategies and Design History Files.
- Manage and track team activities, ensuring milestones are achieved within defined budgets and timelines.
Other
- Typically requires a Bachelor’s degree with 17+ years of industry experience
- 13+ years of years of successful leadership
- Travel Required: 15-25%
- Must be an individual with strong interpersonal, written, and verbal communication skills.
- Must be self-motivated with a collaborative and proactive approach.
