Quality Systems Associate

COLLINS MCNICHOLAS RECRUITMENT

GALWAY

Description. The Quality Systems Associate role provides support to the Global Post-Market Surveillance team to oversee global complaint management and post-market regulatory reporting activities for the Abbott Rapid Diagnostics division. This role will report directly to the Director, Global Post-Market Surveillance. This role is for an 18-month contract. Responsibilities and Duties. Assist in the establishment and implementation of global complaint management and adverse event reporting strategies. Support recurring Complaint Intake and Complaint Entity site stakeholder team meetings. Support site audits as necessary to ensure effective implementation of global standards and procedures related to complaint management and adverse event reporting. Identifies and resolves readily identifiable, clearly-defined problems. Demonstrates skill in data analysis techniques by resolving missing/incomplete information in routine assignments. Carry out duties in compliance with established business policies. Demonstrate commitment to the development, implementation and effectiveness of the division Quality Management System per ISO, FDA, and other regulatory agencies. Possesses and applies fundamental and increasing knowledge of Quality, and its application within ARDx, to the completion of routine assignments. Cross-functional team member – represents Global Post Market Surveillance team in cross-functional teams where business needs require. Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Perform other duties & projects as assigned. Requirements. A minimum of 1 year working in a regulated medical device complaint management function. Experience supporting in-vitro diagnostics products. Bachelor’s degree in a related field (Science or engineering preferable. Knowledge of US and global regulations related to medical device complaint handling and regulatory reporting in accordance with 21 CFR Part 820.198, 21 CFR Part 803, ISO 13485, MEDDEV 2.12-1 and others. Experience working in electronic complaint management systems. Excellent verbal and written communication skills, able to convey appropriate information with clarity and effectiveness. Excellent computer skills including all MS Office applications. Competency in conducting a technical review of documentation/ communications. What you receive in return. 25 days annual leave. Full healthcare for individual only. Pension. Life Assurance. Internal development courses. Maternity leave benefit. Please get in touch to discuss confidentially on elaine.dolan@collinsmcnicholas.ie or click "apply now" 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 www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs!.

1548 days ago