Head of Operation

 

Job Summary 

• Strategic Operations Leadership - Drive operational strategy aligned with business goals, including capacity planning, footprint optimization and long-term growth initiatives.  

• Regulatory & Compliance Oversight - Ensure full compliance with standards such as ISO 13485, FDA regulations and applicable global requirements (e.g., GMP), maintaining audit readiness at all times.  

• Quality Management & Continuous Improvement - Champion a strong quality culture, oversee CAPA, NCR and drive continuous improvement initiatives using Lean/Six Sigma methodologies.  

• Manufacturing & Production Excellence - Oversee daily manufacturing operations to ensure efficiency, yield and on-time delivery while meeting stringent medical device requirements.  

• New Product Introduction (NPI) & Technology Transfer - Lead cross-functional efforts for NPI, process validation (IQ/OQ/PQ) and seamless transfer from R&D to mass production.  

• Cost & P&L Ownership - Drive cost optimization, productivity improvements and eventually take ownership of site-level P&L in preparation for GM responsibilities.  

• Engineering & Process Development - Oversee process engineering, automation, tooling and innovation to improve manufacturability and scalability.  

• EHS (Environmental, Health & Safety) Leadership - Ensure compliance with safety regulations and foster a strong EHS culture to protect employees and operations.  

• Talent Development & Organizational Leadership - Build and develop high-performing teams, succession planning and leadership pipeline (including mentoring future leaders).  

• Customer & Stakeholder Management - Act as a key interface with Sales/clients, ensuring customer satisfaction, managing escalations and supporting business development efforts.  

• Digital Transformation & Systems Integration - Lead the adoption and optimization of digital tools (e.g., MES, ERP, data analytics) to enhance operational visibility, traceability and decision-making in a highly regulated environment.  

• Risk Management & Business Continuity - Identify operational risks (quality, supply, regulatory) and implement mitigation strategies, including contingency and business continuity planning.  

• Commercial & Business Growth Support - Partner with Business Development teams on RFQs, cost modeling and capability presentations to win new business, while aligning operational readiness with growth opportunities.  

• Support ad hoc instruction given by Directors and CEO.  

 

 

Job requirements 

• Bachelor degree or above with at least 15 years of deep knowledge in medical device regulations (preferred), quality systems, manufacturing processes, supply chain, financial management, risk control, leadership and continuous improvement methodologies.  

• Extensive experience leading manufacturing operations, managing cross functional teams, driving quality compliance, scaling production, handling audits, optimizing costs and delivering business results.  

• Strong leadership, strategic thinking, problem solving, decision making, communication, stakeholder management, data analysis, project management, negotiation, adaptability and continuous improvement mindset.  

• Resilient, decisive, accountable, adaptable, results driven, proactive, disciplined, collaborative, ethical, detail oriented, customer focused, calm under pressure and committed to excellence.  

• Good command of speaking and writting English and Madarin/Chinese.  

 

Working Hour : 8am – 5.30pm ( Monday to Friday )