Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

This Opportunity
1. Responsible for maintaining and updating the quality system, working procedure, to monitor the implementation and documentation, to ensure the compliance with local and global regulations.
2. Fulfill the company SOPs, regulatory and quality control.
3. Complete tasks as required and be able to provide comments and feedback in the process.
4. Participate in cross-functional, regulatory, industry association, etc. projects, and be able to provide feedback and suggestions.
5. Solve daily problems based on existing processes and regulatory requirements.
6. This role serves as a key quality and safety post.

Main Tasks & Responsibilities:
1. As the quality representative of the product localization project, participate in the review of deliverables and relevant project meetings to ensure that the deliverables comply with Roche headquarters and local quality regulations and meet the company's business needs.
2. Participate in quality management activities during the product life cycle of the registrant system, including product change management, quality monitoring with entrusted manufacturing companies, product release and review and closure of NC/CAPA/SCAR.
3. Quality Documents & Records Control and Change Control. Keep records. Have clear filing and maintenance of all documents.
4. Coordinate and support for External Audit, Internal Audit.
5. Conduct business in full compliance including but not limited to Roche Secure, Roche Behavior in Business, Roche Competition Law Interactive Dialogues, Roche Safety, Security Health and Environmental Protection.
6. Understand and fulfill the responsibility of line manager's SHE tasks and duties (as defined in SHE handbook).
 

Basic Requirements of the Job:
Education & Qualifications
1. Bachelor degree or above in medical equipment / mechanics / automation / bioengineering / medicine / biochemistry / clinical examination, etc.
2. Proficiency in both spoken and written English.
3. Good command of MS office software application.
4. Understand medical device/drug regulation.
Experience
More than 2 years of experience in medical device production quality management, familiar with ISO13485 management system, GMP and other regulations. Experience in quality management of new medical device product development or localization projects is preferred.

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.