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Dwi Setiyono

Dwi Setiyono

QA & Regulatory Affair Manager

PT Panasonic Healthcare Indonesia

QA & Regulatory Affair Manager





PT Panasonic Healthcare Indonesia

QA & Regulatory Affair Manager

1. Setup, construct and maintain Quality Management System ISO 13485 for Medical Devices, ISO 9001 for General Quality System and now have been setup for ISO TS 16949 for Automotive
2. Coordinate for Regulatory Registration, License, Establishment and Device Listing (JPN-PMDA, MDD, MoH, USFDA, China CQC)
* Pass Japan - PMDA audit in 2011
* Pass MDD CE mark audit in 2011
* Pass US - FDA CGMP Inspection in June 2013
* Pass China - CQC CCC Inspection in July 2013
3. Coordinate for Notified Body audit, Customer audit and Regulatory audit (MOH, JPN-PMDA, EU-MDD, US-FDA, CHINA-CQC/ CCC, KOREA-KFDA)
4. Setup and construct for NEXUS – PRODUCT DATA MANAGEMENT overall Panasonic Healthcare
5. Application for Certificate of Exportation (CoE) and Certificate of free sale (CFS)
6. Representative of Technical Responsible Panasonic Healthcare Indonesia for all product distributed in Indonesia
7. Setup and preparing for Automotive Quality Management System TS 16949.
8. Integrate system QMS ISO 9001 and QMS ISO 16949

Career medium 03
Career medium 03

PT Panasonic Shikoku Electronics Indonesia

QA QC Supervisor

Setup and construct outsource quality system and conduct periodic audit
Coordinate with Purchasing and incoming inspection team
Total almost 112 supplier listed already audited with Panasonic Quality System standard ver.2001


PT Matsushita Kotobuki Electronics Indonesia


Communicate and maintain communication with customer and Panasonic Center Evaluate, study for customer complaint and response
To handle Customer return units and any replacement (part/ product)
Conduct annual survey to measure customes satisfaction

Career medium 06

Universitas Indonesia (UI)

Bachelor, Economics, Operation Management

Universitas Diponegoro

Diploma, Electrical Engineering