Singapore, Singapore
Over 15 years of Quality Control and Production Management experience in medical device manufacturing industry, encompassing production planning, scheduling, process control, product inspection, quality control, inventory control, people management, coaching and cross functional training. Experienced in managing manpower, resources, budgets, expenses and projects to support manufacturing capacity and diversification, product and process transfer as well as digitalization transformation with ERP. Participated in process and yield improvement, cost reduction, capacity expansion and new product introduction. Effective cross functional collaboration, managed stakeholders’ expectations in achieving new product pipeline and ensure business continuity. Experienced as SME in internal and external audits, CAPA, Deviation/OOS investigation, SOP and traceability. Key Competencies: GMP | GDP | ISO 13485 | Manpower Management | Production Planning | Product Inspection | Inventory Control | Process Control | Cleanroom | Data Analysis | Root Cause Analysis | Coaching | Employee Training | Budget Management
• Manage teams of QC Technicians & Team Leads in execution of QC processes, schedule and personnel to ensure smooth operational activities work-flow and work compliance. • Responsible for day-to-day performance of teams’ safety, quality, delivery, cost and productivity. • Oversee resource management and team schedules for smooth execution of daily operational tasks in QC while meeting daily inspection targets and support Work In Progress (WIP) controls within teams. • Ensure proper product release and rework activities per procedures to support delivery requirements. • Manage Deviation/Out-of-Spec report closures, batch dispositions while ensuring proper root cause analysis and CAPA identification. • Manage ongoing activities for existing/new QC employees for training and requalification. • Manage non-routine requests from other departments.
Responsibilities: • Overseeing, managing and ensuring the operation is cost effective, meeting best output, yield, efficiency and quality. • Manage incorporation of new requirement, process and product pipeline in operation. • Oversee and guide the troubleshooting of inspection equipment and process. • Manage and improve inspection process, remove inefficiency and cost reduction plan. • Provide advice on process improvement/changes and ensure all operations meet the regulatory requirements. • Manage cross functional support and collaboration in sample making, root cause analysis, corrective and preventive action, validation activities. • Headcount planning, budgeting and expenses. • Establish departmental policy, goals, objectives to meet company quality system. • Manage departmental KPI. • Oversee and review the performance and development of in-house training programs. • Assist in external audit and inspection.
Responsibilities: • Manage and ensure operation runs smoothly, meeting best output, yield, efficiency and quality. • Manage, plan and draw up schedule based on capacity and capability. • Leading and managing a team of supervisors and leaders in providing technical support to operation. • Assist in providing plans and advice on process improvement, cost reduction, cross functional support, collaboration. • Assist in headcount planning, budgeting and expenses. • Plan and review the performance and development of in-house training programs. • Review and approve QMS related document in the event of department manager’s absence.
Responsibilities (additional responsibilities on top of QC Supervisor): • Assist manager in overseeing scheduling and resources planning, establishing priorities, monitoring progress, revising schedules, resolving problems and reporting progress. • Provide guidance to fellow supervisors in operation monitoring, supervising and troubleshooting.
Responsibilities: • Process design, development, validation and control. • Standard operation procedure, FMEA and control plan preparation. • Troubleshooting, root cause analysis, corrective and preventive action preparation. • Production efficiency monitoring and process improvement. • Prepare training material and conduct in-house training. • Production report preparation.
Responsibilities: • Assist in process design, development, validation and control. • Assist in packaging design and evaluation. • Assist in troubleshooting, root cause analysis, corrective and preventive action preparation. • Standard operation procedure, FMEA and control plan preparation. • Perform sample testing and prepare testing reports.