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General Manager (Medical Devices)

Salary undisclosed

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Key Responsibilities:

  • Oversee all aspects of the operation within the organization and collaborate with other departments to ensure smooth cross-functional communication and coordination.
  • Develop and implement plans to meet company goals and align with ISO 13485 standards.
  • Ensure adherence to ISO 13485 and other regulations, and manage regulatory inspections.
  • Supervise daily operations to maximize productivity and conduct risk assessments to minimize disruptions.
  • Track KPIs and metrics to identify improvements and optimize operations.
  • Build and manage vendor partnerships, negotiating contracts for quality and cost-effectiveness.
  • Oversee manpower planning and monitor sales achievement.
  • Lead projects to enhance efficiency and reduce costs, applying lean manufacturing practices.
  • Oversee the Quality Management System (QMS) and prepare performance reports for management.
  • Ensure compliance with relevant local laws and regulations, as well as company policies and procedures.
  • Prepare for and manage regulatory inspections and audits, and ensure corrective actions are implemented.
  • Manage budgets and forecasts, monitor financial performance, and implement cost-control measures.
  • Participate in conferences and networking events to stay updated on market trends and form partnerships.
  • Handle key customer accounts, oversee after-sales service, and address quality issues.
  • Identify new market opportunities and work with sales and marketing on strategies.
  • Oversee recruitment, training, and performance management, ensuring staff are trained on ISO 13485.
  • Job Requirements:

  • Bachelor’s degree in Engineering, Business Administration, Operations Management, or a related field.
  • Advanced degrees (e.g., MBA) or relevant certifications (e.g., PMP, Six Sigma).
  • Minimum 5 years in a similar role, preferably within a multinational company or senior position in medical device manufacturing or a high-tech sector.
  • Proven experience in Operations Management and successfully leading teams to meet business goals and KPIs.
  • Experience in data analytics is advantageous, with a preference for candidates based in Penang.
  • Strong interpersonal and communication skills, with effective problem-solving abilities.
  • Excellent organizational and project management skills, capable of handling multiple priorities.
  • Ability to manage time effectively and perform under pressure.
  • Focus on product quality, manufacturing processes, and understanding of supply chain and financial operations.
  • Familiarity with lean manufacturing, Six Sigma, and process improvement methodologies.
  • Strong technical knowledge related to medical device manufacturing, financial management, and budgeting.
  • Ability to interpret financial data for strategic decision-making.
  • Exceptional leadership and people management skills to motivate teams.
  • Familiarity with ISO standards and compliance requirements.
  • Experience in developing standard operating procedures (SOPs) and managing after-sales service.
  • Skills in preparing and presenting reports on business performance to senior management or boards of directors.
  • Understanding of compliance strategies, shipping logistics, and banking instruments.
  • Experience with HR procedures and legal matters relevant to the industry.
  • Fluency in English is required; proficiency in Bahasa Malaysia and Mandarin is preferred.