Job Title

Quality Manager, HK

Job Description

In this role, you have the opportunity to

 

• To formulate and implement the Business’ long-range quality, regulatory and compliance policy, and to lead and direct organizational development and process. Improvement in such a way as to ensure that the Business strategic policy and strategic growth targets are met.
  
   

You are responsible for

• To formulate and implement the Business’ long-range quality, regulatory and compliance policy
• Create Q&R awareness level as determined within the organization.
• Assist the QMS (0192) simplification and implementation in Hong Kong
• Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction.
• Manages compliance to FDA regulations and the local Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations
• Manages the review and approval of finished products manufactured for and by the company in accordance with their approved specifications. 
• Manages and implement PMS activities (e.g. product recall, product complaints, AE reporting) etc. 
• Assist the Audit Program for the organization 
• Interact with all areas involved in the product development process, customer services and sales and marketing and provide direction and consultation

To succeed in this role, you should have the following skills and experience

• Bachelor degree or above, BS in Science or equivalent. 
• Technical background is essential. 
• Minimum 6 years experience in quality management system and have experience in working with the medical systems company is an advantage. 
• Experience with working with Hongkong medical device competency authority is preferred. 
• Experience in leading QMS internal audit, CAPA managing, Adverse Event report, and Corrections & Removals reporting per Hongkong Medical device regulation. 
• Rich experience in QMS process development. 
• Well understanding with ISO9001 and ISO13485 standards, knowledge of EU MDD and FDA QSR is an advantage. 
• Excellent communication and interpersonal skills. 
• Positive attitude, will to take the lead for the responsible projects. Can work under high pressure. 
• Computer skills including database management, word processing and spreadsheets are also necessary.
• Good in written and spoken  English and Mandarin, Cantonese Preferred

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