Cache of job #13938135

Job Title

QA Manager

Employer

ICDS Recruitment

Location

Louth

Description

QA Manager - County Louth. OVERALL PURPOSE OF THE JOB: 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. Act as a key member of the Plant leadership team, providing strategic input on all areas of the business. RESPONSIBILITIES: o Manage and Implement Global Quality Objectives at the site level. o Ensure that all devices manufactured meet required quality specifications. o Manage and develop the staff in the Quality department through involvement, delegation, and regular reviews of performance. o Drive Quality Improvement Plans at the site. o Responsible for ensuring adherence to all corporate, external and appropriate regulatory requirements (e.g. ISO, FDA. o Manage quality metrics across the site and ensure adherence to site quality targets. o Liaise on a worldwide basis with corporate quality, engineering, R&D, marketing, and manufacturing staff. o Member of Site Leadership Team, with responsibility to support key initiatives and development strategy for the site. o Acting as Management Representative with specific responsibility for the Quality System. Manage the Batch Release Process to meet Supply Chain Requirements. Analyse customer complaints and modify processes/equipment/operator standards as necessary to eliminate defects. o Implementing and coordinating the CAPA process. o Assigning disposition to non-conforming materials. o Managing quality spend budget and challenging spend where appropriate. o Manage updates to the Quality Manual. o Internal Quality Auditing co-ordination. o Communication with the Notified Body on Quality and Regulatory issues. o Conducting Management Review sessions. o Support Sales and Marketing Customer Centricity Objectives. Also: 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 organisation. Review the performance of the organisation’s Quality System at a minimum of twice per year to ensure its continuing suitability, adequacy, and effectiveness. EDUCATIONAL REQUIREMENTS: Third level qualification in a Quality, Engineering or Science Discipline. RELEVANT EXPERIENCE: o At least 10 years’ experience in Quality environment within a Medical Devices/Pharmaceutical industry. o Excellent knowledge of the ISO 13485 Quality Standard. o A working knowledge of FDA requirements and managing FDA audits. o Demonstrated ability to lead, direct and influence people. o Excellent people management and communication skills. o Strong planning and organizational ability. This job originally appeared on RecruitIreland.com.

Date Added

2026 days ago

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