Quality Assurance Manager
Job Qualifications :
Minimum Bachelors Degree (S1).
Have received training on Audit. Both internal and external.
Know about Good Manufacturing Practices for Medical Devices (CPAKB), Halal Assurance System (SJH), ISO 13485, MDR 2017/745, and also know all the latest regulations for the Medical Device Industry, which can be proven by certification from a designated/accredited institution.
Experience in Quality Management System (QMS) or Control of Operation (COC) is an added value.
Ability to collect and analyze audit evidence.
Ability to create and manage SOPs and quality documents.
Knowledge of audit methods (e.g. Risk-Based Thinking).
Job Descriptions :
Responsible for the implementation of an effective quality system, ongoing CPAKB/SJH training, periodic internal audits, validation, Product Quality Reviews, and Quality Risk Management in all areas related to the manufacture of medical devices.
Manages deviations, including batch deviations, that impact product quality. Implements a change control system and approves changes.
Ensuring that the production of medical devices is consistently monitored and controlled by their intended use, which is to be safe and effective for users, and following established quality specifications.
Conducting the final acceptance or rejection of finished products.
Participate in or initiate the development of the companys Quality Manual and Side Master File (SMF).
Manage the Quality Assurance (QA) department, plan the necessary resources, including the annual operational budget for the QA department.
Implement a system to handle complaints from customers and ensure the elimination of the causes.
Plan and manage the Internal and External Audit Process.
Ensure proper implementation of SOP across the different departments.
Assist the Ministry of Health/Health Department audit team and coordinate actions/responses to findings.
Assist external auditors and coordinate actions/responses to findings.
Ensure the implementation of Quality Risk Management in all departments and processes related to finished product manufacturing.
Information :
- Company : PT Adventa Biotech International
- Position : Quality Assurance Manager
- Location : Jawa Tengah
- Country : ID
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Post Date : 2025-07-28 | Expired Date : 2025-08-27