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 company’s diagnostic division. This role will report directly to the Director, Global Post-Market Surveillance.
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 a 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 behaviour 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
- Bachelor’s degree in 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 technical review of documentation/ communications
For a confidential discussion and more information on the role, please contact Stephen Kelly on 091-706714.