Reporting to the Managing Director I am responsible for all aspects of the companies quality policy,management systems, processes and their implementation. I am the key contact for health authorities, dealing with audits, requests for information and site registrations. I am Based in Dongguan managing quality departments both in China and the UK. Responsible for driving quality improvements and performance globally. Heavily involved in new product development and introduction, process and product validation and project management.

Responsible for all quality activities at the UK manufacturing site and headquarters including ISO 13485 and 9001 certification, QMS management, supplier approval and CAPA processes. Management of the quality team in the UK as well as key company contact for MHRA and FDA.

Key responsibilities include managing Health Authority enquiries and inspections on site (FDA, MHRA, KFDA and PMDA) as well as maintaining/generating new site registrations. Managing the sites internal and external Audit programme including the auditing of suppliers. Identifying cGMP issues and proposing solutions. influencing the strategic vision from a quality perspective, advising on industry trends/standards, and identifying & assesing suitable opportunities for improvement. To provide expertise and advice on FDA systems interpretation. Ensuring GMP compliance in projects by providing Input into all phases of project from conceptual design to final approval

Key Challenges include, working as site QA manager and ensuring all quality functions are carried out on site. Managing audits from inspectors and customers as well as auditing and approving our suppliers and logistics partners. Managing the sites ISO:9001 certification compliance and driving continuous improvement across all departments on site. I am also part of the project team working towards site certification for OHSAS 18001. In addition I also deliver training to staff globally. I must keep abreast of changes to global regulations affecting a large number of end user markets. Provide regulatory and quality guidance/advice to customers, marketing, sales, manufacturing and carry out bespoke training when required. Managing the Product Assurance Department (which provides regulatory, quality and technical data to customers

Working as part of a QA team carrying out quality activities and supporting manufacturing and end users within the scope of ISO:13485 and ISO 9001. Being actively involved with and leading improvements in operations systems and ways of working through mediums such as change controls, continuous reviewing of documents and procedures and through influencing others. Solving manufacturing and other issues through root cause analysis and providing solutions to our customers. I provided training to operations staff on quality and production issues. I was also responsible for the investigation and communication of customer issues or complaints. Ensuring site health and safety guidelines are followed on site and providing guidance when required.