Kerja Sepenuh Masa, QRA - QRA Section Head – Medical Device di Pentamaster Pulau Pinang - Maukerja

QRA / QRA Section Head – Medical Device Job description About the roleEstablishing, monitoring and maintaining the quality system implementations in accordance with the ISO 13485:2016, MDA Malaysia, US-FDA QSR, European MDR and related International Medical Device Regulations. What you’ll be doing Responsible to assist in monitoring and tracking of company quality objectives. Responsible to manage quality document control system in accordance with the ISO 13485:2016 quality management system, US-FDA QSR, European MDR and related International Medical Device Regulations. Responsible to co-ordinate internal audit and conduct process audit in accordance with ISO 13485 quality management system, US-FDA QSR, EU European MDR and related International Medical Device Regulations. Responsible to coordinate for in-house preparation prior to external audit by certification body or customers. Responsible to manage the entire process of product registration of current and new products with various regulatory bodies. Provide regulatory affairs and technical support by working together with marketing, e Research and development, Engineering team on establishing the path of regulatory compliance for new / existing products. Prepare training plan for cGMP and GDP training of all employees of the company as well as supervision of the compliance of the standards. Responsible to ensure the corrective action replies of all internal and external audits discrepancies was closed effectively. Coordinates Change Control process (Document change, design change, production and process change) to ensure appropriate changes and actions are implemented. Responsible for the management of Customer Complaint, Corrective Action and Preventive Action (CAPA) investigation as well as Nonconformances (NC) investigation and process activities. Maintain Risk Management File and coordinate Risk Analysis with other functions & ensure Risk Analysis has been developed, evaluated and reviewed. Corresponded with regulatory authorities regarding planning of registrations, time frames and in case of enquiries. Perform any other pertinent responsibility that may be assigned occasionally as required by Top Management or immediate superior. What we’re looking for Minimum six years of professional experience in regulatory affairs or in quality management system relating to medical devices. A minimum of six years experience in Medical Device based GMP manufacturing operations. Experience working in a GMP, ISO 13485:2016 and related International Medical Device Regulations. Experience in the establishment and development of Greenfield sites is an advantage.