Quality Management System Officer (QMO)

A French company, the URGO Group is currently has presence in 60 countries worldwide, has leading position in all its reference markets and is determined to continue its international expansion. This ambition is supported by ongoing innovations and major investments in research and development, production and clinical research to demonstrate the therapeutic efficacy of products. 3,400 employees are involved in carrying forward this mission in 22 countries. 10 factories world-wide plus contract manufacturing business partners support in serving all our customers worldwide. The URGO Group strives for excellence through the skills, commitment, and initiative of its employees. Our Thai industrial site (Pathumthani) is specialized in the manufacture of medical devices and has 150 employees. The site aims to increase its activity by almost 40% over the next 3-5 years by developing numerous products for its internal and external customers. Quality Management System Officer (QMO) Reports to: Quality Management System Supervisor Role Overview The QMS Officer is responsible for a broad range of Quality Management System activities, including customer complaint handling, internal CAPA follow-up, document control (internal and external), support for internal audits, and general quality/environmental system tasks. The role ensures the organization's operations remain compliant with ISO standards, GMP, and applicable medical device regulations. Key Responsibilities 1. Complaint Handling Register all customer complaints and feedback into the system. Coordinate the investigation process to identify root causes and propose CAPA. Prepare and issue the complaint investigation report for submission to the customer. Follow up on correction and corrective actions until the target date is met. Coordinate with QC when required to block stock and issue an NCP (Non-Conformance Product report) due to product quality risk. Close the complaint report upon completion. Update the risk management file for any impact resulting from complaint-related actions. Support product and process deviation CAPA for process improvement and non-quality cost reduction. File and maintain complaint records. 2. Internal CAPA Follow-up Register all CA (Corrective Action) and PA (Preventive Action) into the system. Submit CA and PA to the relevant auditee for investigation and CAPA feedback. Close the CAPA report upon completion. File and maintain CA and PA records. 3. Change Control Register and update the change control log with the status of each change control number. Inform project leaders and relevant teams of the progress of each change control once documents/records are approved (Green Light, Cancel, Closing). Prepare and update the monthly change control report for project leaders, supervisors, and managers. 4. Internal Audit Prepare the internal audit plan and coordinate with the audit team. 5. Document Control Internal Document Control Control documents of the quality and environmental management system, quality/environmental records, material specifications, and finished goods specifications (both soft file and hard copy). Register change request numbers and assign document numbers. Review and ensure accuracy of the Document Master List and Form Master List. Update the Document Master List and Form Master List. Retrieve invalid and obsolete documents to prevent unintended use. Ensure documents are kept in good condition (avoid deterioration or loss). Destroy invalid and obsolete documents that no longer need to be archived. Distribute valid documents, forms, material specifications, and finished goods specifications, including to external suppliers. Coordinate with all departments for archiving quality and environmental management system documents/records at off-site (supplier) storage. External Document Control Control external documents that form part of the quality and environmental management system documentation but originate from external sources. Register and assign document numbers to external documents. Update the External Document Master List. Ensure the latest revision of external documents is obtained. Support checking and providing requested external documents. Procure updated versions and dispose of obsolete/invalid versions. Inform the team of any updates or obsolete/invalid versions. 6. General Tasks Perform other duties as assigned by the supervisor. Support and cooperate in the preparation of environmental management systems. Support and cooperate in complying with Good Distribution Practice (GDP) requirements for importing or selling medical devices. Prepare monthly reports. Conduct refresher training on GMP/GDPMD for Officer, Admin, and Operator level staff. Handle the PR (Purchase Request) process for department stationery. Authority Decide on the appropriate correction to be carried out for non-conforming products based on complaint investigation findings. Destroy archived documents once the disposal list has been approved by the QAM or QMS Supervisor. Qualifications Bachelor's degree in Science (Microbiology, Biology, or related field). Minimum 3 years of experience in QA & QMS. Computer literacy (MS Word, Excel, PowerPoint, Internet, and other applications). Good command of English (reading, writing, and speaking). Good communication skills — listening, speaking, and writing. Understanding of ISO standards, GMP, or other relevant standards/regulations for medical devices, with the ability to prepare related documentation. Knowledge of Quality Control and statistical techniques. Knowledge of investigation techniques and CAPA handling. Knowledge of product problem-solving. Knowledge of products and manufacturing processes. Welfare and Benefits Provident Fund Staff training and development Fuel/transportation fees Marriage gift Social security Health insurance , Accident Insurance Ordination leave Employee's uniform Funeral payment support Annual trip or party Annual bonus If you aim to challenge yourself with opportunity to show your ambitious and skill. We are ready to welcome. Interested candidates are invited to submit application via A PPLY NOW Urgo Healthcare Products Co., Ltd. 154 Moo 5, Tiwanon Road,T. Bangkadee, A. Muang Pathumthani, Pathumthani