QRC Manager

Job description

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. Job Overview Responsible for ensuring quality and regulatory compliance for SSU Hong Kong business activities across applicable markets, including Hong Kong, Macao, and Mongolia, while driving process effectiveness, operational efficiency, and continuous improvement. Represents SSU Hong Kong in interactions with external authorities and agencies and promotes a strong quality culture within the local organization. Partners with global and local teams to define and implement registration strategies that support timely product approvals by applicable local authorities. Monitors regulatory and standards developments across the relevant markets and communicates applicable changes to relevant stakeholders in a timely manner. Job Responsibilities and Essential Duties Ensure effective local implementation and maintenance of the Global Sales Quality Management System (GS QMS) in alignment with ISO 13485, ISO 9001, and applicable local regulatory requirements. Ensure SSU Hong Kong operates in accordance with GS QMS procedures and applicable regulatory requirements, including but not limited to adverse event reporting, field safety corrective actions, and recall management. Ensure that all products marketed in applicable markets comply with applicable local regulatory and quality requirements throughout their lifecycle. Drive continuous improvement through internal and external audits, CAPA management, management reviews, and periodic quality dashboard reviews with the SSU Hong Kong management team. Monitor, collect, update, and maintain regulatory and standards intelligence for applicable markets, and ensure timely and effective communication of relevant changes to all applicable stakeholders. Lead and manage product registration, renewal, amendment, and related regulatory approval activities in applicable markets, in collaboration with BA QRC and relevant business stakeholders. Report quality system performance, key compliance risks, and improvement needs to the line manager and relevant management stakeholders. Establish and maintain constructive working relationships with local authorities, notified bodies, distributors, suppliers, healthcare institutions, and other relevant external stakeholders. Plan and deliver quality and regulatory compliance training to support local awareness, competency, and adherence to applicable requirements. Perform other quality, regulatory, compliance, or business-related duties as assigned by the line manager. Act as the local quality manager (LQM) and local management representative for GS QMS. Minimum Requirements Bachelor’s degree in science, engineering, medical technology, life sciences, or another relevant discipline. Minimum of 7 years of relevant experience in quality management, regulatory affairs, or compliance within the medical device or healthcare industry. Strong working knowledge of medical device quality management systems and post-market quality processes. Demonstrated supervisory or people management experience, including team leadership, training, coaching, workload prioritization, and performance management. Required Knowledge, Skills and Abilities Strong internal and external communication skills, with the ability to engage effectively with cross-functional stakeholders, management, external authorities, and business partners. Excellent written and verbal communication skills in English and Chinese, with the ability to prepare clear, concise, and well-structured business and compliance documentation. Qualified auditor for ISO 13485 and/or ISO 9001, with practical experience in planning, conducting, supporting, or responding to internal and external audits. About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.