Quality Assurance Lead – ISO & Process Improvement

PT PHC Indonesia; Bekasi; On-site; IDR 70,000,000 - 95,000,000; Full time

Job summary

PT PHC Indonesia is seeking a Quality Assurance Staff to lead outgoing inspections and ensure compliance with global standards. You will prepare and control documentation for new model development and manage quality reports.

Strong attention to detail and English proficiency are essential for success in this role. The team maintains rigorous document control procedures in accordance with ISO 13485, IATF/TS, and ISO 9001, supporting manufacturing of medical devices and components in the Bekasi

Qualifications

• Bachelor's degree in Engineering (Mechanical, Electrical or Mechatronics).
• Strong understanding of electrical systems and instrumentation.
• Good analytical thinking and problem-solving skills.
• Fluent in English (spoken and written).
• Able to read and interpret circuit diagrams and technical drawings.
• Proficient in creating presentations and operating computer tools (Word, Excel, PowerPoint).

Responsibilities

• Act as outgoing inspection leader.
• Prepare and control documents for new model development.
• Perform document control activities in compliance with ISO 13485, IATF/TS, and ISO 9001 standards.
• Create and manage daily, weekly, and monthly quality reports.
• Maintain proper filing and documentation systems.
• Handle market issues and in-house quality problems, including investigation and follow-up actions.
• Monitor and control product quality, manufacturing processes, and quality-related documentation.

Skills

Fluent English

Electrical systems

Reading diagrams

Presentations/MS Office

Education

Bachelor's degree in Engineering (Mechanical, Electrical, Mechatronics)

Job description

PT PHC Indonesia is seeking a Quality Assurance Staff to lead outgoing inspections and ensure compliance with global standards. You will prepare and control documentation for new model development and manage quality reports.

Strong attention to detail and English proficiency are essential for success in this role. The team maintains rigorous document control procedures in accordance with ISO 13485, IATF/TS, and ISO 9001, supporting manufacturing of medical devices and components in the Bekasi