Section Manager, Pe (Patient Monitoring)

Responsibilities: Hiring, training, and mentoring of the process engineering team. Manage and motivate the staff, monitoring them to ensure they meet performance and safety requirements. Manage and supervise resources in process development, product transfer, line expansion and process improvement to enhance product quality, decrease cost and improve manufacturing efficiencies. Work together with the production to ensure the manufacturing processes meet production targets against lowest cost, according to planning and quality requirements. Troubleshooting issues associated with manufacturing processes and performing process simulations. Develop new and cost-effective ways to improve quality, productivity and reduce wastage through process improvement. Involve in validation activities including develop and execute validation test plans. Adopting better manufacturing processes and train operators on improved work methods. Establish statistical methods e.g DOE, SPC used to monitor/improve the process performance. Handle customer complaints, NCRs, CAPAs and implement corrective actions to prevent recurrence. Requirements: At least a Degree in Engineering field or equivalent. Knowledge in ISO 13485 and 21CFR820 would be an added advantage. Analytical, problem-solving and critical thinking skills. Teamwork and interpersonal communication skills. Demonstrated expertise in solving highly technical problem. Strong leadership skill.