Quality Assurance Manager
Life Science Recruitment are sourcing a Quality Assurance Manager to lead the Quality Team at a global medical device manufacturing facility based in Drogheda. This position will oversee a full range of quality functions to the business including, driving quality objectives, specifically those needed to meet requirements for the product and ensuring that they are managed and delivered by relevant functions within the business. This includes the provision of quality support to ensure that the required production, quality and regulatory standards are achieved through moulding, assembly, packaging, sterilization and product release. The successful candidate will act as a key member of the plant leadership team, providing strategic input on all areas of the business.
Roles & Responsibilities
• 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 the 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.
Skills & Qualifications
• The successful candidate will have a strong background in Quality relating to the medical devices/pharmaceutical industry.
• Minimum of 10yrs relatable experience.
• Educated to degree level in Quality, Engineering or a Science Discipline, BEng, or have demonstrable experience.
• Experience of building, motivating, inspiring, leading and managing high performing Quality Teams.
• Excellent communicator who can interact with all levels of colleagues and bring cross team working to its fullest potential.
• Excellent knowledge of the ISO 13485 Quality Standard.
• Working knowledge of FDA requirements and managing FDA audit.
James Cassidy | Tel: +353 (0) 1 5079250