JOB REQUIREMENT / RESPONSIBILITIES
• Heading entire process engineering team in production, tooling, NPI and validation.
• Responsible for injection molding and its associated processes for the medical, automative and technology sectors.
• Lead the activities of process engineering, production/process improvement pertaining to molding process development, mold buyoff, new mold transfer, quality issues.
• Provide documented procedures on buyoff on new / transfer molds prior to mass production release keeping process development as the core activity.
• Lead process validation activities including generation of validation protocols and reports such as IQ, OQ and PQ.
• Ensure that yields and cycle time are in accordance with BOM standard.
• Work in cross-functional group to coordinate with all process-related issues.
• Investigate and implement solutions on process or material related problems.
• Extend support to productivity program such as process automation, tool fabrication and improvement activities.
• Provide adequate support for the cross functional activities such as handling non-conformance product; Initiate actions to prevent recurrence through proper documentation of process instructions, root cause analysis, process flow chart, FMEA, Control Plan.
• Conduct periodical review of process-oriented SOPs & other documentations & keep them up to date a timely basis.
• Drive for continuous improvement projects. Maintain the effectiveness of the validated processes through the understanding of cGMP (current Good Manufacturing practice.
• Sustain continuous improvement plans for zero-defect quality system toward customer satisfaction, and ensure compliance to FDA, ISO and safety regulations.
• Lead as department head to develop and retain high performing employee teams to collaborate and align both business goals and customer demands.
• Perform any other duties as assigned by the reporting head.
EDUCATION / ACADEMIC QUALIFICATION
• Bachelor’s degree / Diploma qualification in plastic processing / chemical / mechanical engineering.
• Master Moulder Certificate 1 or 2.
KEY REQUIRED EXPERIENCE, SKILLS AND ABILITY
• Minimum of 10 years industrial experience in plastic engineering and its processing technique.
• Possess through knowledge and practice on scientific moulding techniques.
• Knowledge of handling all sort of plastic polymers and moulds.
• Familiar and hands on with medical device validations.
• Expert in analysing cycle time and provide support to RFQs.
• Knowledgeable in Risk Assessment, Failure mode analysis, Process Validation, Continuous Improvement and Design of Experiments (DOE).
