QA Engineer

• 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.

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