QA Compliance Director

Corin ,
Cirencester, Gloucestershire
More Details

Overview

Job Description

Corin, an orthopaedic medical device business, are currently looking to to recruit into a new position of QA Compliance Director to direct the development, communication and implementation of quality policies, procedures, systems enhancements, budget, capital expenditures and projects to ensure effective, compliant quality systems supporting products manufactured, sourced and distributed. This includes continuous improvement and driving quality metrics throughout the total quality process. In providing quality leadership and direction for Quality Assurance/Quality Control the Compliance Director has ultimate responsibility for developing and executing strategies to strengthen Corin quality leadership position in our industry and prepare the organisation to meet the challenges of continued growth. You will be based at the global head office in Cirencester, Gloucestershire, which is the home to nearly 400 employees. Corin provides a progressive and dynamic work environment where you can take control of your career, be accountable and drive positive change. The role may require some travel to the other countries including the US, Australia, Japan and Europe. Corin is going through an exciting period of growth with its new investment partner Permira driving global technological / robotic advancements in the implant of hip and knee surgery which in turn delivers better patient and surgical outcomes. The key responsibilities for the QA Compliance Director are to: * Strategically plan for quality objectives annually based on outputs from Quality Management reviews and QA Metrics * Create, implement, establish and maintain a Quality System in accordance with ISO13485/MDR / 21CFR820 and other regulations as required. * Create, maintain, and manage robust Quality Systems compliant to 21CFR820, EU-MDD, EU-MDR, ISO13485, and other applicable regulations * Manage the Quality Control and Quality Assurance teams including performance assessment, setting goals and objects, coaching and developing staff. * Direct the quality control and assurance team to * Ensure product quality during the production process and adherence to departmental/company procedures and to applicable regulations and i.e. cGMP, ISO, FDA, EU-MDD, EU-MDR, etc. * Conduct quality and process audits internally and at supplier locations. * Maintain current library of process documentation, complaints and analyze products and returns to establish quality trends and implement corrective actions. * Lead all inspections/audits required from regulatory authorities, customers and prospects. * Provide necessary interactions with regulatory authorities, audits, customers and prospects. Represent Corins quality function with regulatory agencies to answer questions, plan meetings, obtain information, and otherwise facilitate regulatory communications. * Create and present Quality Management Reviews which contribute to discussions regarding Companys quality, compliance, improved manufacturing, distribution operations, packaging, materials management, and product life cycle management. * Clearly communicate QA results, concerns/issues, project status, corrective actions/status to the management team and other stakeholders. * Proactively minimize or eliminate quality and regulatory issues to help prevent any impact of adverse regulatory activities on the corporate reputation, market or bottom line. * Manage cost efficiency, quality assurance initiatives, budget, capital planning, performance reports, and project management and key performance measurements. * Participate and often lead harmonization of Corin Groups QA globally, and supports other Corin Group sites with expertise where required. * Maintain QS database; lead implementation of eQMS (including developing strategy for configuration, validations, training, migrations, etc. for each module). Requirements The QA Compliance Director must have the following essential skills and background to be considered for the role; * A Bachelor degree in engineering and/or science discipline; Masters if Science degree in engineering and/or science discipline from a top university. * A seasoned Quality leader with an extensive experience in Quality Assurance within medical devices industry (FDA 21 CFR 820, ISO 13485, EU MDD, EU MDR). * Demonstrated success in operating in stable and turnaround situations * Significant global quality assurance experience including knowledge of US and international regulations / GMP requirements * Significant man-management experience in leading global quality assurance teams * Demonstrated outstanding communication and presentation skills to audiences with various levels of Quality knowledge and expertise * Demonstrated ability to influence, and interact effectively across a global organization, building effective relationships internally and externally. * Strong aptitude of Medical Device QMS and regulatory requirements including, but not limited to, ISO13485 and U.S. FDA 21CFR820 * Strong/resu

People also viewed