QA Engineer - Manufacturing (Fixed Term)
Core
Apply Quality Engineering methods and standards to ensure manufacturing quality, compliance, and continuous improvement in a regulated volume manufacturing environment.
Role type
Manufacturing Quality Engineer (Fixed Term)
Builds
Reliable manufacturing quality performance, validated processes, and compliant production systems.
Domain
Medical Device Manufacturing / Quality Engineering
Required skills
Quality Systems, Manufacturing Quality, risk management, process validation, structured root cause analysis, Quality by Design, digital assurance (CSV/CSA), data-driven decision making, regulatory compliance, audit support, continuous improvement methodologies
Preferred skills
Medical device industry experience, AI tools for efficiency, MES/digital quality exposure, advanced analytics, automation, Quality by Design, manufacturing readiness
Technologies
MES, CSV, CSA, AI tools, advanced analytics
Responsibilities
Support manufacturing readiness and new product introduction with quality planning and validation; Apply quality standards to ensure consistency and standardization; Use quality data to identify trends and recommend preventive actions; Partner with engineering and operations to integrate quality requirements early; Perform or support internal, external, and supplier audits; Ensure compliance with ResMed QMS and regulatory standards; Provide training and guidance on risk management and process validation.
Seniority
Mid-level, hands-on IC