Director, Quality Assurance, APAC

Overview

The primary responsibility of the Director, Quality Assurance, Customer Support and Distribution (CSD), APAC is to ensure the effectiveness of the quality management system for the customer support and distribution centers within the regions. Accountable for the performance and overall health of the QMS within APAC, the Director guides the team to ensure compliance with internal and external requirements and positive customer experiences. This role provides leadership and direction to the various groups within the Quality Assurance function in APAC to implement and carry out global initiatives to ensure that expectations and goals are clear and understood.

Reporting to: Senior Global Director, Quality Assurance, Customer Support and Distribution ​ 

Responsibilities

• Assurance the QMS for Cook entities within APAC regions to meet all relevant regulations including but not limited to: ISO13485, US FDA CFR Part 820, State Council Order No. 739- China, PMD Act, Law Act 145- Japan, Medical Device Management Act- Taiwan, Medical Devices Act- Korea, Good Distribution Practices-Thailand, etc.
• Provide support to developing markets and regions without regulations to ensure best in class expectations of Cook are met and maintained.
• Assurance of good distribution practices application and fulfilment of economic operator roles, e.g. importer and distributor, in country representatives
• Proactive regulatory intelligence monitoring and preparing the teams for changes in standards/regulations within APAC. 
• Direct leadership to ensure compliance of the QMS with global QA policies, procedures and direction. 
• Develop and direct strategic plans (projected 5 years) for quality organization ensuring strategic global alignment and harmonization where possible.  
• Direct and coordinate the team with overall responsibility for ensuring that the QMS in APAC is implemented, maintained and understood by all employees, while meeting all relevant external regulatory requirements.  
• Coach teams to develop creative ways to cultivate a quality culture  
• Lead and direct with Global mindset to support CSD organization 
• Provide regular direction, feedback and corrective action on performance, preparing and delivering annual performance and salary reviews for directs reports. 
• Develop direct reports through ongoing coaching and mentoring for continued employee growth and team succession planning.  
• Maintain overall accountability for the performance of the APAC QMS; proactively communicating the effectiveness of the QMS and any need for improvement to executive management ensuring action is taken to correct any identified deficiencies in a timely manner. ​ 
• Accountable for the customer complaints process, ensuring that customer complaints are dealt with appropriately by the appropriate teams.  
• Ensure support from Quality Assurance to other departments within Cook Medical and other Cook companies. 
• Monitor trends and analyse key Quality Metrics. 
• Direct quality costs and ensure a full understanding of departmental expenditure and budget. 
• Work collaboratively with the relevant business stakeholders, vendors and functional groups on new business opportunities, projects and improvement initiatives. Provide Quality support and guidance to ensure compliant roll out of project goals 
• Maintain strong links with the Quality Assurance community within Cook Medical and medical device industry.  
• Contribute and work as part of the global leadership team to help create a synergistic and cohesive environment. 
• Act as a Continuous Improvement advocate, working with the Continuous Improvement Team, driving Continuous Improvement philosophy and practices 
• Delegate for Senior Director, Global Quality Assurance 
• Supporting the voice of Cook and our patients in industry by commenting on proposed guidance’s and regulations. 
• Represent CSD Quality Assurance at a global level and participate in working groups to drive improvements within Cook.
• ​Ensure that Cook Medical’s Code of Conduct is considered in all business matters carried out on Cook Medical’s behalf.

Qualifications

• Extensive experience in a quality environment, medical industry, in APAC region.
• Extensive management experience leading Quality professionals.  
• Bachelor’s degree or equivalent in Quality, Science or Engineering.   
• ​Working knowledge and experience applying ISO13485 and regional regulations for PMDA & TMG , MFDS, TFDA, US FDA, EUMDR, NMPA & SHMPA, and other health authorities desirable. 
• Knowledge and experience of Quality Assurance, Quality Engineering and Regulatory Affairs, manufacturing and distribution operations. 
• Excellent communication and inter-personal skills. 
• Excellent Leadership skills  
• Project Management Skills desirable 
• Excellent analytical, problem solving and organizational skills 
• Excellent collaboration and interpersonal skills, with a track record of developing strong working relationships globally and with business partners. 
• Ability to work constructively in a matrix-management structure. 
• Ability to work as part of a global management structure 
• Willingness and availability to travel on company business.