Sr. Operations Quality Director
Core
Lead manufacturing quality across Asia manufacturing sites, ensuring product quality, patient safety, regulatory compliance, and operational excellence.
Role type
Senior Operations Quality Director
Builds
Medical device manufacturing operations across Asia
Domain
Medical device manufacturing / Healthcare technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality management systems, regulatory compliance, risk management, auditing, continuous improvement methodologies, cross-functional leadership, talent development, FDA inspection readiness, supplier collaboration
Preferred skills
Site quality leadership, multi-site/region quality leadership, medical device/pharma/biotech industry experience, organizational capability assessment, quality culture transformation
Technologies
None explicitly stated
Responsibilities
Lead manufacturing quality across Asia sites; Drive regional Quality strategy with Global leaders; Partner with senior leaders to strengthen quality culture; Provide oversight for quality management systems; Assess site performance and drive improvements; Engage site leadership for quality initiatives; Lead FDA and regulatory inspection readiness; Develop QA/QC/reliability systems; Build quality leadership pipelines; Facilitate sharing of best practices; Direct cross-functional collaboration with suppliers and agencies; Foster culture of accountability and continuous improvement
Seniority
Senior, hands-on IC with significant people leadership