Director, SW Quality – Consumer Applications

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the Software Quality Assurance teams for Consumer Applications and Data Platform Solutions.

• Set priorities and delegate tasks effectively.

• Utilize customer and consumer insights to foster continuous enhancements aligned with strategic objectives.

• Encourage cross-functional collaboration and adherence to quality and regulatory standards.

• Develop and communicate key metrics related to software development.

• Mentor and guide teams on project planning, requirements, design, and testing procedures.

• Create risk-based, streamlined SDLCs for Class I/II exempt applications and components.

• Collaborate with R&D to ensure compliance of development and testing processes with current regulations.

• Identify compliance deficiencies and revise relevant procedures with departmental collaboration.

• Lead discussions on risk management activities and mitigation strategies.

• Prepare the team for audits by regulatory agencies.

• Provide leadership during the Design/Phase Review process to ensure compliance with the Product Development Process (PDP).

• Organize, manage, and monitor team efforts to achieve milestones within budgetary and scheduling constraints.

⛳️ Requirements

• Bachelor's degree in a technical field.

• Over 15 years of experience in the industry.

• More than 9 years of successful management experience in a related field.

• Strong expertise or working knowledge of FDA 21 CFR Part 820 Quality System Regulation.

• Strong expertise or working knowledge of FDA 21 CFR Part 11 Electronic Records and Electronic Signatures.

• Proficient in SDLC GxP tools, including ALM for software, configuration management, and defect management.

• In-depth understanding of IEC 62304 compliance.

• Familiarity with Software as a Medical Device, software in medical device IoT environments, digital health, and clinical decision support tools.

• Knowledgeable in automated testing methodologies.

• Well-versed in FDA software validation, medical-device software premarket, and cybersecurity guidance.

• Knowledge of ISO 14971 risk management for medical devices.

• Understanding of GxP validation and GAMP.

• Familiar with FDA Computer Software Assurance.

• Experienced with electronic ALM systems for requirements, risk, testing, defect, and configuration management.

• Willingness to travel 10–15% of the time.

🏝️ Benefits

• Comprehensive benefits package.

• Opportunities for growth on a global scale.

• Career development through in-house training programs and/or qualified tuition reimbursement.

• Home office work environment.

• Flexible workplace options may be available.

• Direct access to life-changing CGM technology.

• Innovative, industry-leading organization committed to employees, customers, and communities.