Engineer III, QA (Senior Quality Assurance Engineer)
Core
Leading and implementing quality initiatives to address system inadequacies, ensure compliance with global standards, and foster continual improvement in processes and products within the Asia Distribution Centre and Global Repair Centre.
Role type
Senior Quality Assurance Engineer (Operations/Compliance)
Builds
Quality systems, compliance frameworks, and operational processes for distribution and repair centers
Domain
Life Sciences / Medical Devices / Logistics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality assurance leadership, CAPA planning, risk management, validation protocol development, temperature excursion management, regulatory audit preparation, process improvement methodologies, mentoring
Preferred skills
Cross-functional collaboration, complex problem solving, escalation management
Technologies
ISO9001, ISO14001, ISO13485, ISO14971, FDA 21CFR Part 820, MDSAP, cGMP
Responsibilities
Lead quality initiatives to address system inadequacies, develop temperature excursion management strategies, ensure regulatory readiness for audits, drive practical process improvement, mentor junior quality staff
Seniority
Senior, hands-on IC with mentorship responsibilities
