Director of Quality, Malaysia Operations
Core
Define and execute site strategies to assure compliance to the quality system and international regulations of the medical industry by managing quality operations and engineering teams for manufacturing processes and finished products.
Role type
Senior IC quality director (medical device manufacturing)
Builds
High-quality medical devices and compliant manufacturing processes
Domain
Medical device manufacturing / Quality Engineering
Required skills
Quality operations management, Quality Engineering, Regulatory compliance (ISO 13485), Statistical tools (MSA), Root cause analysis, Budget management, Talent planning, Strategic planning
Preferred skills
Six Sigma certification, MBA, Certified Lead Auditor, German fluency
Technologies
SAP, Office Package, Agile
Responsibilities
Direct responsibility for Malaysia Operations quality functions (IQC, MRB, PMC, FQI, DHR), Develop site and regional strategies, Create inclusive culture, Manage quality assurance and compliance activities, Control quality operations budget, Collaborate with operations teams, Track recurring issues and escalate for corrective action, Collect and monitor product quality data, Develop and improve quality operational metrics, Provide support and guidance to leads, Perform Organization Talent Plans, Plan resource requirements
Seniority
Director, strategic leadership & hands-on management