Job Description

Responsibilities:

• Supervises production assembly and packaging according to established processes, techniques and policies.
• Plan and schedule Production Build to meet shipment requirement.
• Work with Production Planners on production schedule, build plan and material availability
• Organize and ensure cycle count in Production is carried out. Analyze cycle count result, account for variance and implement appropriate corrective action
• Ensure technicians and operators are trained and maintain training matrix/record
• Lead in-process audit activities to ensure compliance of established procedures and ensure all necessary Quality records are updated timely
• Co-ordinate with Engineering to ensure AP/IPP is comprehensible and understood by operators.
• Co-ordinate, plan and execute Engineering evaluations run, collection of data etc.
• Motivate and lead a team of technicians and operators to achieve the production goals and objectives
• Publish periodic production status report, monthly scrap, etc and conduct review meeting
• Conduct routine production meeting with all supporting department
• Ensure timely disposal of NCM parts, member of MRB team.
• Track and maintain traceability records such as starting s/no for 1st lot; QN implementation and changes in process and/or corrective action implementation etc.
• Lead Lean Six Sigma and Kaizen activities in Production
• Ensure compliance of all existing Quality management system, ISO & cGMP etc.
• Setup and start up NPI or Product transfer line, including cGMP line
• Maintain, repair and manage ancillary support for the factory

• Degree in Mechanical/Manufacturing Engineering or in any related discipline
• Minimum 7 years of experience in lean manufacturing assembly process and test environment
• Experience in leading a team of production staff in a regulated manufacturing environment
• Understand Total Quality Control and Lean Manufacturing methodologies
• Diligent, quality conscious and team player with Leadership quality
• Proficient of MS Office Application
• Knowledge of Lean Six Sigma with at least Green Belt certification is desired
• Experience in leading small group activities in Lean Six Sigma projects, quality improvement projects, root cause analysis and kaizen activities
• Excellent communication, presentation and people management skills
• Knowledge of SAP or any other ERP system
• ISO13485 trained, experience in running a FDA regulated product manufacturing line