Quality Management System Specialist

PT Technomed Asia; Kota Bandung; On-site; IDR 100.000.000 - 200.000.000; Full time

Job summary

A foreign owned medical accessories manufacturer in Bandung is seeking a Quality Management Specialist. The role entails designing and maintaining the Quality Management System (QMS) in accordance with ISO 13485, managing audits, and ensuring documentation compliance. Candidates should have a Bachelor's degree and 2-3 years of related experience. Strong analytical and communication skills are required.

Qualifications

• Minimum 2-3 years' experience as a quality specialist in a manufacturing company.
• Understanding of ISO 13485 and CPAKB standards required.
• ISO 13485 Internal Auditor and Lead Auditor certification is a plus.

Responsibilities

• Design, implement, and maintain a QMS in accordance with ISO standards.
• Manage internal audits and handle external audits.
• Monitor and evaluate product checking results related to quality.

Skills

Quality management

Data analysis

Document practices

Analytical thinking

Communication skills

Education

Bachelor's Degree in Engineering or related field

Tools

MS Office

Job description

Overview

Ensuring the Quality Management System (QMS) is up to date according to the standards used as guidelines and monitoring the implementation of QMS to ensure it is functioning effectively.

Responsibilities

• Design, implement, and maintain a Quality Management System (QMS) in accordance with ISO 13485 and CPAKB standards.
• Manage internal audits and handle external audits.
• Manage all quality-related documentation ( procedures, work instructions, etc.) to ensure accuracy and compliance.
• Conduct internal training on quality procedures and policies.
• Perform data analysis related to quality.
• Monitor and evaluate trending product checking results related to quality.

Qualifications

• Education: Bachelor's Degree in Engineering or related field.
• Minimum 2-3 years' experience as a quality specialist, preferably in a manufacturing company.
• Understanding of ISO 13485 and CPAKB standards is required.
• ISO 13485 Internal Auditor and Lead Auditor certification is a plus.
• Good English language skills both verbal and written.
• Well organized with strong document practices.
• Experience with MS Office.
• Good analytical thinking and strong communication skills; fast learner.

About Technomed Asia

Technomed Asia is a foreign owned company specialized in the production of medical accessories. Main products are electrodes for EEG (brain studies), EMG (muscle studies) and intra-operative monitoring. Technomed Asia produces accessories under the Technomed brand, as well as for several OEM customers worldwide. Its strength is the production of relatively small quantities of highly customized products. Technomed Asia has its own independent ISO 13485 certified quality system and is FDA registered as well as appointed as a manufacturer of medical accessories for the Japanese market.