QMS SPV

About the role

The QMS Supervisor oversees the implementation, maintenance, and development of Quality Management System (QMS) in accordance with ISO 9001, ISO 13485, and applicable medical device regulations. This role manages quality documentation, coordinates internal and external audits, handles corrective and preventive actions, and manages medical device product registration and licensing processes.

Key responsibilities

• Oversee implementation, maintenance, and development of Quality Management System (QMS) according to ISO 9001, ISO 13485, and applicable medical device regulations
• Ensure all quality management system documents and procedures are applied, controlled, and updated regularly
• Coordinate internal audits, external audits, and monitoring of audit findings follow-up
• Monitor implementation of Corrective and Preventive Action (CAPA) and ensure effectiveness of corrective measures
• Monitor and evaluate achievement of quality objectives and support Management Review implementation
• Manage and coordinate medical device product registration processes, including preparation of technical and administrative documents
• Ensure completeness, accuracy, and timeliness of registration document submission and product distribution license renewal
• Manage product registration database and monitor validity of licensing and company certifications
• Coordinate TKDN submission processes and compliance with SIINas reporting and related certifications
• Monitor changes in medical device industry regulations and ensure implementation within the company

About you

• Minimum S1 degree in Engineering, Pharmacy, Chemistry, Biology, or related field
• Minimum 3 years of experience in Quality Management System, Quality Assurance, or Regulatory Affairs, preferably from medical device manufacturing industry
• Understanding of ISO 9001:2015 and ISO 13485:2016 implementation
• Understanding of CPB (Cara Pembuatan Alat Kesehatan yang Baik) requirements and Indonesian medical device regulations
• Experience in QMS document management, internal audits, CAPA, and Management Review
• Understanding of medical device registration and distribution licensing processes through the Ministry of Health system
• Knowledge of TKDN certification processes, SIINas reporting, and product testing is an added value
• Strong analytical, problem-solving, coordination, and communication skills
• Detail-oriented, organized, with leadership qualities and ability to work to targets
• Active proficiency in English and ability to operate Microsoft Office, particularly Excel, Word, and PowerPoint