Director, QA - Product Development Processes

About the Company

Dexcom Corporation (NASDAQ: DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Founded 25 years ago with a mission to transform diabetes management, Dexcom has expanded its vision to empower people to take control of their health through personalized, actionable insights. The company is driven by thousands of passionate employees worldwide and aims to become a leading consumer health technology company while continuing to develop solutions for serious health conditions.

About the Team

The Design Quality Engineering (DQE) team at Dexcom is a collaborative and motivated group that drives Design for Excellence (DfX) methodologies across the product lifecycle. The team leads strategies and supports outcomes in Design Control, Software Development Lifecycle (SDLC), Design Transfer, and Risk Management quality system processes.

Responsibilities

• Serve as the accountable global process owner for Dexcom’s Design Control and Risk Management quality system processes, including ownership of all procedures, instructions, templates, and tools to ensure end-to-end traceability.
• Proactively improve processes using state-of-the-art standards, regulations, and organizational feedback.
• Engage in industry-wide initiatives around Medical Device standards and guidance.
• Map processes within and adjacent to the quality system.
• Develop and drive training programs to ensure confident execution across the organization.
• Measure process effectiveness over time in Quality Management Reviews.
• Act as a strategic subject matter expert (SME) for complex situations within processes on project teams or specific issues.
• Lead Design Control and Risk Management Process Activities through continuous improvement, CAPA, or Quality Improvement Plans.
• Lead, organize, develop, and grow an organization of site Business Process Owners.
• Represent Design Control and Risk Management during regulatory audits and inquiries alongside work product authors.
• Promote cross-functional understanding and adherence to quality standards, processes, and regulatory requirements.

Requirements

• Minimum of 13 years of experience in medical device development.
• At least 8 years in progressively responsible leadership roles.
• Global Design Control process strategic leadership experience.
• Global Risk Management process strategic leadership experience (ISO 14971 and IEC 60812).
• Experience integrating Risk Management into Quality Management Systems (FDA QMSR and ISO 13485).
• Experience implementing enterprise Design Control and Risk Management IT systems.
• Expertise in Value Stream Mapping and Business Process Mapping.
• Instructor-led training expertise.
• Corrective and Preventive Action (CAPA) expertise.
• Regulatory Inspections and Audits expertise.
• People leadership, team development, and organizational design experience.
• Ability to adapt to shifting priorities and manage multiple initiatives.
• Exceptional interpersonal, written, and verbal communication skills.
• Self-motivated with a collaborative, proactive, and accountable approach.

Typically requires a Bachelor’s degree with 15+ years of industry experience, preferably in a technical discipline. 9+ years of successful management experience in a relevant industry is required. Engineering degree preferred.

Benefits

• A front-row seat to life-changing CGM technology and the #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 employees, customers, and communities.

Pay

$164,200.00 - $273,600.00

Schedule

Flexible workplace with a primary location in a home office. Must live within commuting distance of an assigned Dexcom site (typically 75 miles/120km). Travel required: 5-15%.