Quality System Manager

ICDS Recruitment

Galway

Quality System Manager - Galway. In this role you will be responsible for managing the processes and people within the Quality Systems department to ensure that the company is in compliance with all applicable regulatory and business requirements. Core duties: Manage the Quality System team and ensure that both regulatory and business requirements are met in the daily running of the department. This includes motivation, training and appraisal of QS staff. Responsible for processes within Document Control, Customer Quality and Master Data area. To take a leadership role in driving improvement initiatives in the Quality Management system across the site. Drive and enhance a compliance culture thoughout the site. Providing Quality Systems support for all business units and sites. Preparing for and supporting external audits. Ensure adequate monitoring and measurement of processes, and reporting same to management. Ensure Quality System processes are lean, compliant, user-friendly and are well understood throughout the organisation. Be responsible for Health & Safety within assigned areas. Interested applicants should have: Degree in Quality Assurance or Degree in Science/Engineering with an additional qualification in Quality Assurance. Should be an experienced Quality Systems Manager with a minimum of 3 years' experience at that level within the Medical Device or related industry. Excellent working knowledge and proven track record in the all aspects of ISO13485 and FDA QSR requirements. Regulatory experience / knowledge. Good organisation, supervisory, technical writing and investigation skills are required. Excellent communication and interpersonal skills. Proven ability to influence. This job originally appeared on RecruitIreland.com.

1779 days ago