- Provide leadership, coaching and performance management to the QA team
- Serves as Quality In-country Representative/Management Representative
- Manage the QA department setting accurate schedules and deploying required resources, ensuring delivery against department goals and objectives.
- Provide strategic planning (projected 5+ years) for quality organization within China to global supply chain leadership, including importation and in-country manufacturing/product design
- Ensure proactive monitoring of global compliance requirements
- Direct and coordinate COOK’s quality management system, assuring ongoing compliance with quality and industry regulatory requirements.
- Implement continuous quality improvement initiatives in line with ISO 13485 standard and all regulatory requirements relevant to sales of COOK products.
- Ensure implementation of continuous quality improvement initiatives in line with ISO 13485 standard and all regulatory requirements relevant to sales of COOK products
- Excellent communication skills that include the ability to compile relevant QA reports and disseminate quality assurance trends and information to Key COOK staff locally, as well as globally, to ensure the organisation is up to date with current quality requirements.
- Provide support to and liaise with other functional units within COOK including the provision of effective QA input to various departments.
- Coordinate and support on-site audits conducted by external providers and evaluate audit findings / implement appropriate corrective actions.
- Collaborate with the Regulatory Affairs Director in activities that facilitate the preparation of Regulatory Submissions for COOK and provide support to the RA department in reporting adverse events to relevant authorities.
- Participate in management meetings and provide monthly summaries of quality issues to the senior management team.
- Ensure post market activities, as required by regulations and operations, are completed, e.g. PER, recall, investigations, etc., relevant to global supply chain and in-country manufacturing oversight.
- Serve as the single quality point of contact for Cook China and represent the company during interactions with local and international health authorities and in industry forums
- Provide strategic guidance and lead Post Market Reporting team, ensuring reports meet compliance requirements.
- Support quality needs for Cook products manufacturing and design operations within China
- Support and collaborate with distribution partners, ensuring compliance standards are met
- Support Global CSD organization, by participating in global meetings and continuous improvement projects
- Support career development of QA department
- Tertiary qualifications required, with the capability to understand and apply good technical understanding of the processes, business needs and to ensure that all requirements are understood and met.
- Experience working within a highly regulated environment such as Medical Devices, Pharmaceuticals or Biotech preferred.
- Demonstrated quality assurance experience in a management position leading a team.
- 8-10 years of industry and leadership experience
- Fluent in English and Chinese (written and oral)
- Use Microsoft suite of products (Word, Excel, PowerPoint)
- 4 year Degree
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