Director, QA - Product Development Processes San Diego, California Posted

Meet the team:

The Design Quality Engineering (DQE) team at Dexcom is made up of incredibly passionate, collaborative, motivated, and competent people that think big, serve with integrity, and follow through on their commitments without fail. This team takes ownership in driving Design for Excellence (DfX) methodologies across the product lifecycle of Dexcom's on market products and future innovations, as well as leading strategies and supporting outcomes across our Design Control, Software Development Lifecycle (SDLC), Design Transfer, and Risk Management quality system processes.

• You will be the accountable global process owner for Dexcom's Design Control and Risk Management quality system processes. This includes:
• Ownership of all Design Control and Risk Management procedures, instructions, templates, and tools in all lifecycle phases of Dexcom products that ensure complete end-to-end traceability.
• Proactively improve processes with state-of-the-art standards, regulations, and organizational feedback.
• Engaging directly in industry-wide initiatives around Medical Device standards and guidance.
• Responsibility for process mapping within and to adjacent processes of quality system.
• Developing and driving training program for the organization that ensures confident execution.
• Measurement of process effectiveness over time in Quality Management Reviews.
• Acting as strategy SME for complex situations within processes on project teams/specific issues.
• You will act as the Quality lead for Design Control and Risk Management Process Activities driven through continuous improvement, CAPA, or Quality Improvement Plans at Dexcom.
• You will be responsible for leading, organizing, developing, and growing an organization of site Business Process Owners.
• You and your team will be responsible for representing Design Control and Risk Management during regulatory audits and inquiries alongside work product authors.
• You will promote cross-functional understanding and adherence to quality standards, quality processes, and regulatory requirements.

• Global Design Control process strategic leadership experience
• Global Risk Management process strategic leadership experience (ISO 14971 and IEC 60812)
• Risk Management integration into Quality Management Systems experience (FDA QMSR and ISO 13485)
• Experience implementing enterprise Design Control and Risk Management IT systems
• Value Stream Mapping and Business Process Mapping expertise
• Instructor-led training expertise
• Corrective and Preventive Action (CAPA) expertise
• Regulatory Inspections and Audits expertise
• People leadership, team development, and organizational design experience
• You must have a minimum of 13 years of experience in medical device development.
• You bring at least 8 years in progressively responsible leadership roles.
• You demonstrate an ability to adapt to shifting priorities and manage multiple initiatives.
• You possess exceptional interpersonal, written, and verbal communication skills.
• You are self-motivated with a collaborative, proactive, and accountable approach.
• Engineering degree preferred.

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

• 5-15%

• Typically requires a Bachelor’s degree with 15+ years of industry experience
• Requires a degree in a technical discipline
• 9+ years of successful management…