Taipei, Taiwan, Taiwan
5 hours ago
QA Associate Manager – Taiwan & Hong Kong
Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2023 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com


 

Principal Responsibilities
Be the Management representative for Convatec Taiwan and Hong Kong. Establish, implement, and maintain the appropriate procedure related to local regulatory requirements and ensure compliance to the requirements. Work closely with RA and other appropriate partner to compile, prepare, review, and submit QSD submissions to the local health authorities. Execute QA activities with internal Convatec counterparts such as Sales, Marketing, Supply Chain partners and distributors as appropriate. Management of all post market actions and associate activities. Overseeing local Labeling Process and control. Ensure the label approved by RA which is updated to label master file is implemented at the distribution warehouse.

Specific responsibilities of the role include, but are not limited to:

Being the QMS Management Representative for Convatec Taiwan and Hong Kong. Review and manage the development, writing, implementation and maintenance of appropriate procedures related to regulatory activities and ensure documentation is in compliance with the local regulatory requirements.Work with different functions to implement established processes. Develop full QMS for Taiwan to meet GDP requirements in the country. Ensure company business operation comply with requirements.Reporting to top management on the effectiveness of the quality management system and the need for improvement.Ensure that awareness of applicable regulatory requirements and quality management system requirements is enhanced throughout the organization. Conduct trainings to ensure team members including the new comers and local distributors’ are following Convatec’s reporting process.Keep abreast of new and updated regulatory requirements and communicate the changes to the relevant stakeholders as necessary.QSD/ GMP Certificate submission, maintain and timely update of registration status for the manufacturing sites into the relevant registration and listing databases.Support any quality aspects relating to distribution chains. Execute QA activities with internal Convatec counterparts, logistics partners and distributors as appropriate.Overseeing local Labelling Process and control. Ensure the label approved by RA which is updated to label master file is implemented at the distribution warehouse.Manage customer complaint handling process, including the reporting and follow up with distributor in Taiwan. Coordinate the credit notes on monthly basis. Ensure product safety issues and product associated events are reported to the local health authorities if required.Closely following up critical complaints and updating the correction plan to the team on periodical basis. Taking the responsibility of communicating with customers for critical complaints, including the action plan agreed with the team.Execute, manage, and close post market activities for example recalls and corrections. Responsible to consolidate the response form, reconciliation of recall quantity, prepare and submit all reporting activities associated with a removal or correction with the local health authorities and ConvaTec Global Compliance Team.Ensure GxP suppliers are qualified as required in according to Global procedure, to assist in the audit if necessary, in order to support the supplier qualification process.Support as requested by line manager with all other requests for information and documentation associated with quality assurance.

Qualifications and Experience

A minimum of a bachelor’s degree in science, Engineering, or Medical Technology or at least 5 years of experience in Medical Device industry is requiredExperience in post-market quality assurance (QA) in medical device industry for Taiwan and Hong Kong is preferred. Have good understanding of the Quality System Regulations, product recalls and field safety correction action, and labeling requirementsExperience in Quality Management Systems, such as ISO-13485:2016, Taiwan QSD registration is required. Certified ISO-13485 internal quality auditor is desirable.English communication skill in verbal and written.Strong communication and project management skills, ability to multi-task and deliver within tight timelines

Our ambitions will bring the very best out in you. You’ll be pushed to aim higher and really own your work. You’ll be encouraged and supported to make things happen, too. It can be challenging. But, as the progress you make will help improve the lives of millions, it’ll be worth it.  

 

This is stepping up to a challenge.  

 

This is work that’ll move you 

 

#LI-JG1

#LI-Hybrid 


 


 

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