Factory Quality Manager ｜requirements: ISO 13485

Location：Kawasan Industri Terpadu Batang, Kavling H10, Jalan Otomotif 1, Desa Ketanggan, Kecamatan Gringsing, Kabupaten Batang, Jawa Tengah 51281, Indonesia

About the role

This is a quality management leadership position responsible for overseeing quality across the full process including incoming materials, in-process production, finished goods shipment, and customer complaints. The role involves formulating departmental quality objectives, supervising subordinate engineers, and driving continuous improvement across the organization.

Key responsibilities

• Formulate and decompose departmental quality objectives, and supervise the performance and daily work execution of subordinate engineers

• Maintain awareness of work progress through regular meetings and report reviews, and carry out task allocation and guidance

• Organize departmental training to enhance the team's quality awareness and professional capabilities

• Oversee and manage the quality status of the full process including incoming materials, in-process production, finished goods shipment, and customer complaints

• Chair daily and regular quality meetings at the branch company, and drive production, technical, and other departments to collaboratively resolve quality issues

• Track and drive the implementation of corrective and preventive actions to ensure quality issues are effectively closed out

• Lead the handling of customer complaints and major internal abnormalities, and coordinate resources for rapid response and containment

• Supervise and follow up on the root cause analysis of major issues by responsible departments, and verify execution and effectiveness of improvement measures

• Liaise with the headquarters Quality Department, accurately submit support requirements, and drive localized implementation of headquarters strategies

• Coordinate with internal departments such as production and technical teams to resolve quality disputes and remove bottlenecks in management processes

About you

• Bachelor's degree or above in Quality Engineering, Biotechnology, or other related fields

• Familiar with the ISO 13485 medical device quality management system

• Hands-on experience in quality management

• Strong communication skills and team management capabilities

• Fluent English in listening, speaking, reading, and writing