Quality Assurance Manager

Bd Medical

Louth

BD is a global medical technology company focused on improving drug therapies, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. BD provides an environment which enables our highly talented workforce to be the best at their professions. We are always seeking people who have a passion and commitment to join our Company on its journey in ‘advancing the world of health’. Our site in Drogheda is commencing a major upgrade and refurbishment of all facilities. In addition to this investment there are a number of new lines being brought into production. This BD facility is the only one globally which manufactures one of our new PosiFlush™ products. With this steady growth and expansion taking place we are now recruiting a Quality Assurance Manager to lead the Quality Team, providing a full range of quality functions to the business including, driving quality objectives, specifically those needed to meet requirements for the product, ensuring that they are managed and delivered by relevant functions within the business. This includes providing the quality support to ensure that the required production, quality and regulatory standards are achieved through moulding, assembly, packaging, sterilization and product release. Act as a key member of the Plant leadership team, providing strategic input on all areas of the business. Manage and Implement Global Quality Objectives at the site level. Ensure that all devices manufactured meet required quality specifications, through moulding, assembly, packaging, sterilization and release. Manage and develop the staff in the Quality department through involvement, delegation, and regular reviews of performance as established in IIGs. Drive Quality Improvement Plans at the site. Responsible for ensuring adherence to all BD, external and appropriate regulatory requirements (e.g. ISO, FDA. Manage quality metrics across the site and ensure adherence to site quality targets. Liaise on a worldwide basis with BD quality, engineering, R&D, marketing, and manufacturing staff. Member of Site Leadership Team, with responsibility to support key initiatives and development strategy for the Drogheda site. Acting as Management Representative with specific responsibility for the Quality System. Manage the Batch Release Process to meet Supply Chain Requirements Analyze customer complaints and modify processes/equipment/operator standards as necessary to eliminate defects. Implementing and coordinating the CAPA process. Assigning disposition to non-conforming materials. Managing quality spend budget and challenging spend where appropriate. Manage updates to the Quality Manual. Internal Quality Auditing Co-ordination. Communication with the Notified Body on Quality and Regulatory issues. Conducting Management Review sessions. Support Sales and Marketing Customer Centricity Objectives. Evaluating and reporting on the performance of the Quality Management System and the needs for improvement to Senior Management. Promoting the awareness of regulatory and customer requirements throughout the organization. Review the performance of the organization’s Quality System at a minimum of twice per year to ensure its continuing suitability, adequacy, and effectiveness. The successful candidate will have a strong background in Quality within a medical devices/pharmaceutical industry with a minimum of 10yrs PQE. You will be educated to degree level in Quality, Engineering or a Science Discipline, BEng, or have demonstrable experience. You will have experience of building, motivating, inspiring, leading and managing high performing Quality Team. You will be an excellent communicator who can interact with all levels of colleagues and bring cross team working to its fullest potential. You will have excellent knowledge of the ISO 13485 Quality Standard. You will have a working knowledge of FDA requirements and managing FDA audit. You must have excellent people management and communication skills and be able to demonstrate Strong planning and organizational ability. You can look forward to a rewarding career, great benefits package, collaborative working and opportunities to expand your skills in this fast moving, dynamic and agile business. If you’re a team player who is passionate about healthcare and we’ve just described your career aspirations, then please click on the APPLY button. This job originally appeared on RecruitIreland.com.

2188 days ago