- Entry level
- No Education
- Salary to negotiate
- Act as Authorized QA representative for ADC China.
- Responsible for organizing the formulation, implementation and sustain of quality management system.
- Maintenance of the quality system to meet the requirements of China GSP for Medical Devices, ISO 9001 and ISO 13485.
- Implementation of affiliate related divisional quality procedures and local procedures. Create/revise local procedures as required
- Conduct internal audits. Prepare teams for global audits
- Primary contact for external auditors and government inspectors on-site.
- Coordinate Management Review meetings
- Primary contact in the country for all Quality related matters
- Supports management to ensure effective operation of the business while maintaining compliance with policies, procedures and legal and regulatory requirements
- Ensure appropriate training plans, and timely completion of training for ADC Affiliate employees.
- Handling of customer requests regarding quality related issues
- Interaction with the customer service and the vigilance group with regards to potential reportable events, medical events and field actions.
- Responsible for reporting Field Actions, recalls and Medical Events to authorized agency.
- Translation approval of technical documentation
- Proofreading of product labeling with respect to country specific requirements
- Ensure compliance of contracted warehouses and distributors with China regulations and Abbott policies and procedures.
- Create CAPAs in response to an audit observation or nonconformance. Ensure timely completion and effectiveness of corrective actions
- Qualification and approval of local suppliers and service providers. Maintain Approved Supplier list
- Guide relevant departments to implement regulations and rules concerning medical devices
- The quality head of medical device distributing enterprises shall have a college degree or above or an intermediate professional and technical title or above of medical device related majors (related majors refer to medical devices, biomedical engineering, machinery, electronics, medicine, biological engineering, chemistry, pharmacy, nursing, rehabilitation, laboratory science and management, hereinafter inclusive), and at the same time have working experiences on quality management of medical device distribution for more than three years.
- Minimum of 7 years working experience in the field of Quality Management in Medical Device Industry.
- Understanding of China GSP for Medical Devices, ISO 13485 and/or ISO 9001 requirements.
- ISO 13485 training / certificate is preferred.
- Able to effectively communicate in English: speaking, listening, reading and writing.
- Experienced user of Microsoft Office software: Word, Excel, and PowerPoint
China Shanghai : 388 Nan Jing Road West
Yes, 10 % of the Time
SIGNIFICANT WORK ACTIVITIES:
About the company
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and www.facebook.com/AbbottCareers, on Instagram @AbbottGlobal, and on Twitter @AbbottNews and @AbbottGlobal.
We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.