Collins McNicholas

Summary 

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

Requirements

  • 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.

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