Quality Assurance Lead, Medical Devices & ISO Compliance

Pt Phc Indonesia; Bekasi; Presencial; IDR 66.960.000 - 100.440.000; Jornada completa

Descripción de la vacante

PHC Indonesia is seeking a Quality Assurance Staff to uphold product quality and regulatory compliance at our Bekasi facility. The role focuses on outgoing inspection leadership and ensuring readiness for new model development.

You will prepare and control critical documents, perform ongoing ISO 13485, IATF/TS, and ISO 9001 conformity activities, and generate quality reports. Strong analytical and English skills are essential.

Formación

• Bachelor’s degree in Engineering (Mechanical, Electrical, or Mechatronics).
• Fluent in English (spoken and written).
• Able to read and interpret circuit diagrams and technical drawings.
• Proficient in Microsoft Word, Excel, and PowerPoint.

Responsabilidades

• 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.

Conocimientos

Engineering background

Electrical systems

Analytical thinking

Fluent in English

Read circuit diagrams

MS Office

Educación

Bachelor’s degree in Engineering

Descripción del empleo

PHC Indonesia is seeking a Quality Assurance Staff to uphold product quality and regulatory compliance at our Bekasi facility. The role focuses on outgoing inspection leadership and ensuring readiness for new model development.

You will prepare and control critical documents, perform ongoing ISO 13485, IATF/TS, and ISO 9001 conformity activities, and generate quality reports. Strong analytical and English skills are essential.