QMS - ISO Officer
Entry Level
Full-Time
Working Mode : WFO
Not Displayed
Job Responsibilities
- Develop, implement, and maintain the Quality Management System in accordance with ISO 13485:2016, ISO 9001:2015, and local regulatory requirements (CPAKB).
- Establish and review quality system standards, procedures, and documentation to ensure compliance with company and legal requirements.
- Handle and coordinate international audit processes, including preparation of documentation, auditor liaison, and closing audit findings.
- Coordinate communication and collaboration among departments to ensure effective QMS implementation.
- Monitor quality KPIs and prepare regular reports for management.
Job Requirements
- Minimum Bachelor Degree (S1) in Industrial Engineering, Quality Management, Electromedic, Biomedic, Electro or a related field.
- Strong understanding of ISO 13485, ISO 9001, ISO 14971, and CPAKB requirements.
- Knowledgeable in internal and external audits procedures, risk management, and documentation control
- Highly detail-oriented, structured, and good in cross-department communication.
- Willing to be placed in Surabaya.
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Electromedic Regulatory Compliance
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Jawa Timur, Kota Surabaya
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