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A leading medical device manufacturer in Indonesia is seeking a Production Manager to ensure compliance with industry standards like CPAKB and ISO 13485. The successful candidate will develop production plans, control production costs, and manage resources while promoting workplace safety. Ideal applicants will have a Bachelor's in Mechanical Engineering and at least 5 years of managerial experience in manufacturing. This role involves continuous improvement efforts and internal audits to maintain quality management systems.
Ensure all production, sterilization, and documentation activities comply with CPAKB, GMP, and ISO 13485 standards to meet quality specifications consistently.
Develop periodic production plans, coordinate with PPIC/Supply Chain regarding capacity forecasts, and develop machine requirement specifications (URS).
Manage resources and improve employee competence and morale through coaching, mentoring, and continuous training.
Investigate problems to their root cause, make corrective decisions (CAPA), and coordinate across departments for effective solutions.
Control production costs to stay within the approved budget and compile production accountability reports (monthly/annual).
Set and monitor department KPIs, and plan for continuous improvement of facilities and processes.
Be actively involved in internal audit programs (both as an auditor and auditee) and ensure that the quality management system is running effectively.
Direct sterilization operations, maintain process performance, and foster a culture of workplace safety in the sterilization environment.
Minimum Bachelor's degree in Mechanical Engineering with a minimum GPA of 3.00.
Have 5–10 years of experience in manufacturing, with a minimum of 5 years at the managerial level in the medical device industry.
Understanding of CPAKB, GMP, and ISO 13485.
Possess strong leadership and solid managerial skills.
Strong analytical and conceptual thinking skills.
Able to create production plans and make decisions to solve problems.
Proficient in Microsoft Office.