Senior QA Engineer

Responsibilities

• Lead and inspire high-performing teams by fostering collaboration, accountability, and continuous development.
• Develop, implement, and maintain SOPs and quality systems in compliance with ISO 13485 and MDSAP regulations.
• Oversee end-to-end management of NCP and CAPA processes across multiple sites.
• Identify and mitigate systemic quality risks using data-driven trend analysis and root cause investigation.
• Conduct structured root cause analysis using methodologies such as A3, 8D, or DMAIC.
• Manage large-scale quality projects, aligning resources and timelines to achieve measurable results.
• Support distribution operations in meeting quality, delivery, and cost targets through continuous improvement.
• Communicate quality performance metrics, audit findings, and project updates to leadership and cross-functional teams.

Requirements

• Bachelor’s degree in engineering, Quality Management, Compliance, or a related field.
• 5 years of experience in quality assurance or quality control within a manufacturing or distribution environment.
• 2 years of leadership experience managing quality professionals in a multi-site or matrixed environment.
• Expertise in regulatory compliance, process validation, and quality system management (ISO 13485, MDSAP, and FDA).
• Strong interpersonal, relationship-building, and communication skills.

Preferred Qualifications

• Experience in change management and process improvement.
• Knowledge of structured problem-solving techniques (e.g., A3, DMAIC, 8D).
• Familiarity with quality systems within a global or regional distribution environment.
• Excellent negotiation and multitasking skills with the ability to prioritize business needs.

About the Company

ResMed creates life-changing health technologies that empower millions of people in more than 140 countries to live happier, healthier lives. Our AI-powered digital health solutions, cloud-connected devices, and intelligent software make home healthcare more personalized, accessible, and effective.