Urgent: Quality Systems Specialist

Our client leading medical device company dedicated to improving patient outcomes through innovative solutions. Based in County Mayo, are looking to hire a Quality Systems Specialist as they expand operations. The Role: As the Quality Systems Specialist you will play a pivotal role in managing and enhancing the companys Quality Management System (QMS) to ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable standards. Responsibilities: Quality Management System: Manage and maintain the QMS, ensuring compliance with relevant standards and regulations (ISO 13485, FDA, EU MDR, etc.). Document Control: Oversee the creation, review, approval, and archiving of quality documents, including procedures, work instructions, and records. Internal Audits: Plan, conduct, and report on internal audits to ensure compliance with the QMS and identify areas for improvement. CAPA Management: Lead Corrective and Preventive Actions (CAPAs) to address non-conformances and drive continuous improvement. Training: Develop and deliver quality-related training programs to employees, ensuring awareness and understanding of quality requirements. Supplier Quality: Collaborate with suppliers to ensure quality standards are met and assist in supplier audits as needed. Regulatory Inspections: Support external audits and inspections by regulatory authorities, including preparation, facilitation, and follow-up actions. Data Analysis: Monitor and analyze quality metrics, trends, and KPIs to identify opportunities for improvement. Change Control: Manage change control processes to ensure all modifications are compliant with quality and regulatory standards. Requirements: Bachelors degree in Engineering, Science, or a related field. 3+ years of experience in a quality role within the medical device or regulated industry. Strong knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR requirements. Experience with QMS software and document management systems. Excellent problem-solving and analytical skills. Strong organizational skills with the ability to manage multiple priorities. Effective communication and interpersonal skills. Internal or Lead Auditor certification (desirable). For more information and a confidential discussion on the role, please contactMichelle Mc Inerney. Skills: Quality Systems Engineer