Manager, Quality Engineering
Core
Lead quality engineering activities including design control, risk management, validation, and regulatory compliance for engineered components and sub-systems in healthcare and advanced manufacturing.
Role type
Manager, Quality Engineering (blended technical leadership and people management)
Builds
Engineered components and sub-systems for mission-critical applications (minimally invasive surgery, robotics, 3D metal printing)
Domain
Healthcare and advanced manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design control, risk management, validation, regulatory compliance, root cause analysis, corrective and preventive actions (CAPA), statistical tools, process improvement, cost of poor quality (COPQ) reduction
Preferred skills
Supervisory or team leadership experience
Technologies
Quality management systems, statistical tools
Responsibilities
Lead and manage quality engineering activities including design control, risk management, and validation; Supervise and coordinate daily activities of quality team members; Ensure compliance with regulatory and quality management system requirements; Conduct root cause analysis and drive corrective and preventive actions (CAPA); Collaborate cross-functionally to improve product quality and reliability; Perform audits and identify areas for process improvement; Maintain quality records, reports, and trend analysis; Provide technical guidance and mentorship to engineers and team members; Drive cost of poor quality (COPQ) reduction initiatives; Foster team engagement, development, and retention
Seniority
Manager, frontline supervisory leadership
