Senior Quality Assurance Executive

Primary Purpose This position is responsible for managing product complaints, Field Corrective Actions (FCA) and non-conformance (NC) activities to ensure compliance with regulatory and company quality requirements. The role supports the timely resolution of quality issues, drives continuous improvement through data analysis and root cause investigations, and contributes to regional and global Quality Assurance projects to strengthen the Quality Management System (QMS) and maintain high standards of product quality and customer satisfaction. Key Accountabilities • Assist in the implementation and maintenance of the Quality Management System (QMS) by assessing the impact of global quality standards and ensuring effective adoption of quality procedures, policies and processes • Manage product complaint handling activities, including data analysis, trending, and investigation, to identify process improvement opportunities and drive operational excellence • Assess and report adverse events to relevant regulatory authorities in accordance with applicable regulations, company procedures, and reporting timelines • Coordinate and execute Field Corrective Actions (FCA), monitor implementation progress, and provide regular status updates and feedbacks to regional leads • Collaborate with cross-functional stakeholders/departments to oversee product quarantine, disposition, and release activities, ensuring compliance with quality and regulatory requirements • Support Non-Conformance (NC) and Corrective and Preventive Action (CAPA) processes, including root cause analysis and investigation, implementation of corrective actions, and verification of effectiveness • Maintain quality-related documentation, filing system and quality records to ensure compliance, traceability, and audit readiness • Support supplier qualification and evaluation activities to ensure suppliers meet established quality and compliance standards • Support internal, external and corporate audit activities • Perform other ad hoc QA duties or projects as assigned by Manager Inherent Requirements • Bachelor’s degree or Diploma holder, major in science, quality management or related fields • Minimum 4 years of Quality Assurance experience in the Medical Device, Pharmaceutical, Healthcare, or related regulated industry • Knowledge of ISO 9001 requirements and experience participating in internal or external audits is an advantage • Hands-on experience in complaint handling, field corrective actions, non-conformance management, and CAPA processes is an advantage • Strong analytical and problem-solving skills with experience applying root cause analysis methodologies such as: 5 Whys, Fishbone (Ishikawa) Diagrams, Failure Mode and Effects Analysis (FMEA) • Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions and make sound quality-related decisions. • Highly organized, results-oriented, adaptable, and capable of managing multiple priorities in a fast-paced environment • Good command of both written and spoken English and Chinese (Cantonese/Mandarin) • Proficient in Microsoft Office applications, including Excel, Word, PowerPoint, and Outlook Why it's Great To Work At Olympus: At Olympus, we are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply with your CV to: hr.ocap@olympus.com . Please note that only shortlisted applicants will be contacted. All personal information provided will be treated in strict confidence and used solely for recruitment purposes. The personal data of unsuccessful applicants will be securely destroyed upon completion of the recruitment process in accordance with applicable data privacy requirements.