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 Asia Distribution Centre and Global Repair Centre.
Role type
Senior Quality Assurance Engineer (QA)
Builds
Quality systems, compliance frameworks, and validated cold chain distribution processes
Domain
Life Sciences / Medical Devices / Cold Chain Logistics
Deliverable
client delivery
Required skills
Quality systems management, cGMP regulations, ISO standards (13485, 9001, 14001, 45001), risk management, root cause analysis, CAPA, change control, process validation, internal auditing, statistical analysis, technical writing
Preferred skills
Experience in cold chain logistics, medical devices, pharmaceuticals, or biotechnology
Technologies
TrackWise, SAP, E1
Responsibilities
Develop and implement quality initiatives to address system inadequacies, lead cold storage testing and validation protocols, drive resolution on product damages, ensure regulatory readiness for audits, mentor junior quality staff, champion practical process improvement
Seniority
Senior, hands-on IC with leadership responsibilities