Cache of job #14016351

Job Title

Quality Systems Engineer


Collins Mcnicholas Recruitment




Responsibilities & Qualifications: Job Responsibilities: Actively stays current with external and internal quality system standards and requirements. Providing Quality Systems support for the Galway site. Support QMS integration activity across the Galway site. Responsible for coordinating and managing all external audits. Responsible for managing the site internal audit process. Responsible for managing the site internal CAPA process. Approvals as defined on Oracle. Identifies deficiencies in quality systems and defines systematic corrective actions. Develops effective quality metrics and communicates the results to key stakeholders using reports, presentations, and dashboards. Ensure compliance and drive improvements in QS processes. Assists in the preparation and maintenance of records associated with the management review process. Participates in Quality Systems projects under the direction of the Quality Director as well as other duties as assigned. Monthly Manufacturing Training Report (provided to HR, accounting for all training data analysis. Key Requirements: Degree in Quality Assurance or Degree in Science/Engineering with an additional qualification/experience in Quality Assurance. A minimum of 2 years experience as a Quality Engineer within the Medical Devices or Pharmaceutical industry. Strong working knowledge and proven track record in the all aspects of ISO13485 and FDA QSR requirements. Regulatory experience / knowledge. Excellent communication and inter-personal skills. Proven ability to influence. Excellent attention to detail and report writing skills. Highly organized with strong ability to prioritize tasks and work on own initiative. Trained Auditor ideally lead auditor training and/or experience. For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs! This job originally appeared on

Date Added

64 days ago