QUALITY ASSURANCE MANAGER
A quality assurance manager will be responsible for maintaining and extending the company quality assurance system ISO13485 to cover the existing and new product lines. In addition, the QAM shall lead, coordinate, and maintain the regulatory related applications and affairs, such as CE Mark, FDA510k and China NMPA regulatory approval and reporting processes. This position will take the overall responsibility in assuring that the company’s Hong Kong and China Quality and safety system requirements are effectively established, implemented and maintained in compliance with CGMP’s and other regulatory requirements.
LOCATION
HONG KONG
EMPLOYMENT TYPE
Permanent
What You’ll Do
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Overall responsibility for assuring that the company’s Hong Kong and China sites comply with all relevant regulations and standards.
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Manage and maintain the certification of ISO 13485, CE Mark, FDA510k, NMPA, etc., of the products of the company.
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Direct quality personnel in the establishing, training, implementing and monitoring of quality and safety procedures.
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Facilitate customer and supplier matters relating to the company’s quality system.
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Manage the suppliers of the company and ensure that the suppliers are adhered to the company’s quality and safety guidelines.
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Develop the Quality and Safety System procedures to ensure company’s overall Quality performance and its compliance to regulations and standards.
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Assure that all employees of company are trained with good understanding of all current regulatory and standard requirements, and ensure that the employees are up to date on any recent updates on regulations and standards.
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Host and assist external medical device related audits. Document the audit results, report and advice the company’s executive management regarding all finding, observations and any resulting Corrective Actions.
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Conduct internal quality and safety audits and trainings at regular intervals to assure that the quality and safety system complies with the established Quality and safety system requirements.
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Report to the executive management at defined intervals on the company’s Quality System performance to ensure its effectiveness.
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Manage the coordination, review, investigation and documentation of complaints relating to the company’s product, and reporting to the respective regulatory bodies as required.
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Chair Quality and Safety System Management meetings which gather and report on the company’s Product Quality and Safety System.
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Lead the development of the Software Validation Plan and test cases.
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Responsible for all other duties as assigned.
Who You are
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Possess a bachelor’s degree or above in science, engineering, medical technology or related disciplines, with at least 8‐year post‐qualification experience and at least 3 years in quality assurance management role in the field of medical device or related fields.
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With IP experience is a significant advantage.
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Proven leadership skills.
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Supervisory and management experience.
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Excellent communication and interpersonal skills.
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Proficiency in written and spoken English. Cantonese and Mandarin are required.
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Experience with ISO 13485, FDA510, NMPA, CE Mark etc., preferred.
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Travel in China and internationally.